Job Search Results for medical device regulations
Feb 18, 2026
Mundelein, IL
|
Administrative Assistant
|
Contract
|
$26 - $32 (hourly estimate)
{"JobID":496082,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-88,"Longitude":42.26,"Distance":null},"State":"Illinois","Zip":"60060","ReferenceID":"CHI-03b88789-cfec-4b1a-a4f3-15b6923492e7","PostedDate":"\/Date(1771387674000)\/","Description":"Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R\u0026D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Adverse Event Specialist","City":"Mundelein","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Bachelor\u0027s degree in a relevant field.1+ year of experience working in complaint handling, MDR evaluation, post market surveillance, regulatory affairs, or other relevant experience.Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.Experience in a regulated industry (pharmaceutical / medical device / food and beverage industry).Strong analytical and critical thinking skills with the ability to apply updated decision logic consistently.Strong time management skills to meet strict timelines, cross functional communication skills, and critical thinking skills.","Skills":"Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).Experience working in environments requiring large scale retrospective reviews or high volume documentation processing.Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.","Industry":"Administrative Assistant","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":32.0000,"SalaryLow":25.6000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}
Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint... remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Apr 13, 2026
Mundelein, IL
|
Administrative Assistant
|
Contract
|
$32 - $40 (hourly estimate)
{"JobID":518271,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-88,"Longitude":42.26,"Distance":null},"State":"Illinois","Zip":"60060","ReferenceID":"CHI-ebedd0db-a2b4-4792-a5bc-d92da1eb0323","PostedDate":"\/Date(1776111834000)\/","Description":"Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R\u0026D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Adverse Event Specialist","City":"Mundelein","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Bachelor\u0027s degree in a relevant field.5+ year of experience working in complaint handling, MDR evaluation, post market surveillance, regulatory affairs, or other relevant experience.Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.Experience in a regulated industry (pharmaceutical / medical device / food and beverage industry).Strong analytical and critical thinking skills with the ability to apply updated decision logic consistently.Strong time management skills to meet strict timelines, cross functional communication skills, and critical thinking skills.","Skills":"Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).Experience working in environments requiring large scale retrospective reviews or high volume documentation processing.Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.5+ years of hands-on experience working in a clinical setting, such as a BSN or RN background with direct patient care experience in high-acuity environments including ICU, PCU, ER, or Operating Room units.","Industry":"Administrative Assistant","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":40.0000,"SalaryLow":32.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}
Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint... remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Jan 16, 2026
Mundelein, IL
|
Administrative Assistant
|
Contract
|
$20 - $25 (hourly estimate)
{"JobID":483956,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-88,"Longitude":42.26,"Distance":null},"State":"Illinois","Zip":"60060","ReferenceID":"CHI-e46cf710-aae7-4b14-84b2-4ce6d4012725","PostedDate":"\/Date(1768605073000)\/","Description":"Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R\u0026D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Adverse Event Specialist","City":"Mundelein","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Bachelor\u0027s degree in a relevant field.1+ year of experience working in complaint handling, MDR evaluation, post market surveillance, regulatory affairs, or other relevant experience.Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.Experience in a regulated industry (pharmaceutical / medical device / food and beverage industry).Strong analytical and critical thinking skills with the ability to apply updated decision logic consistently.Strong time management skills to meet strict timelines, cross functional communication skills, and critical thinking skills.","Skills":"Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).Experience working in environments requiring large scale retrospective reviews or high volume documentation processing.Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.","Industry":"Administrative Assistant","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":25.0000,"SalaryLow":20.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}
Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint... remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Apr 10, 2026
Raritan, NJ
|
Chemical Engineering
|
Contract
|
$32 - $40 (hourly estimate)
{"JobID":517477,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-74.639,"Longitude":40.5719,"Distance":null},"State":"New Jersey","Zip":"08869","ReferenceID":"NNJ-f7fb00e1-dd59-4881-b7cb-506c93e0072c","PostedDate":"\/Date(1775830465000)\/","Description":"A large medical device client of ours is looking for an Analytical Chemist to join their NMR spectroscopy team. This individual will apply Nuclear Magnetic Resonance Spectroscopy techniques to support research and development, identify trace unknown impurities in complex polymer matrices, degradation products of polymer systems, small molecule/polymer interaction products, conduct extractable/leachable studies, maintain Nuclear Magnetic Resonance Spectrometer, Interpret test results and author scientific reports, and collaborate with inter-disciplinary colleagues such as toxicologists, engineers, polymer chemists, etc.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Analytical Chemist (NMR)","City":"Raritan","ExpirationDate":null,"PriorityOrder":0,"Requirements":"-PhD in Chemistry (can be recent graduate) -Classes in organic, inorganic, or polymers chemistry -Experience with NMR spectroscopy -Hands on experience with running samples through NMR and analysis of data -Experience characterizing and looking at reaction mechanisms","Skills":"-Previous medical device exposure-NMR specific project experience in PhD program","Industry":"Chemical Engineering","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":40.0000,"SalaryLow":32.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}
A large medical device client of ours is looking for an Analytical Chemist to join their NMR spectroscopy team. This individual will apply Nuclear Magnetic Resonance Spectroscopy techniques to... support research and development, identify trace unknown impurities in complex polymer matrices, degradation products of polymer systems, small molecule/polymer interaction products, conduct extractable/leachable studies, maintain Nuclear Magnetic Resonance Spectrometer, Interpret test results and author scientific reports, and collaborate with inter-disciplinary colleagues such as toxicologists, engineers, polymer chemists, etc.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Mar 05, 2026
Valencia, CA
|
QA
|
Perm
|
$125k - $140k (estimate)
{"JobID":502948,"JobType":["Perm"],"EmployerID":null,"Location":{"Latitude":-118.56,"Longitude":34.41,"Distance":null},"State":"California","Zip":"91355","ReferenceID":"LAX-35d284ea-b337-4542-af8d-6890d124417e","PostedDate":"\/Date(1772731872000)\/","Description":"A client in the medical device space is seeking a Sr. Software Quality Assurance Engineer to join their organization for a defined two-year term to backfill a team member assigned to internal projects. The ideal resource will be well versed in Quality SW principles within the medical device industry and have deep expertise in risk assessment, testing, and design validation. This resource should be detail oriented with strong documentation and able to identify risks and process improvements on their own to share with cross functional teams including R+D, Marketing, Regulatory, etc. This resource?s time will be split up into 50% design validation activities, 30% SDLC work, and 20% risk management through testing. This role will be hybrid, onsite 3 days per week in Valencia, CA.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Sr. Software Quality Engineer","City":"Valencia","ExpirationDate":null,"PriorityOrder":0,"Requirements":"?Bachelor?s degree in Computer Science, Engineering, or related field?5+ years of experience in Software Quality related rolesoWell versed in testing processes/methodologies and risk assessment?Experience in Medical Device industry or other highly regulated spacesoWell versed with manual system-level testing in regulated environments?Deep understanding of the SDLC per IEC 62304 and IEC 82304oKnowledge of programming languages like csharp, cplusplus, Swift, Node.js, Java/Javascript, Python, etc. ?Risk Management experience working with ISO 14971","Skills":"?Advanced Degree in a related field?Experience with Neuromodulation products?Exposure to CAPA/Complaint handling or external audits?Quality Engineering Certifications (CQE or CSQE)","Industry":"QA","Country":"US","Division":"IT","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":140000.0000,"SalaryLow":125000.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}
A client in the medical device space is seeking a Sr. Software Quality Assurance Engineer to join their organization for a defined two-year term to backfill a team member assigned to internal... projects. The ideal resource will be well versed in Quality SW principles within the medical device industry and have deep expertise in risk assessment, testing, and design validation. This resource should be detail oriented with strong documentation and able to identify risks and process improvements on their own to share with cross functional teams including R+D, Marketing, Regulatory, etc. This resource?s time will be split up into 50% design validation activities, 30% SDLC work, and 20% risk management through testing. This role will be hybrid, onsite 3 days per week in Valencia, CA.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Mar 18, 2026
Mundelein, IL
|
Administrative Assistant
|
Contract
|
$32 - $40 (hourly estimate)
{"JobID":508381,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-88,"Longitude":42.26,"Distance":null},"State":"Illinois","Zip":"60060","ReferenceID":"CHI-4c112355-7038-4592-9b38-f4ce0745c5cb","PostedDate":"\/Date(1773871227000)\/","Description":"Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R\u0026D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Adverse Event Specialist","City":"Mundelein","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Bachelor\u0027s degree in a relevant field.5+ year of experience working in complaint handling, MDR evaluation, post market surveillance, regulatory affairs, or other relevant experience.Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.Experience in a regulated industry (pharmaceutical / medical device / food and beverage industry).Strong analytical and critical thinking skills with the ability to apply updated decision logic consistently.Strong time management skills to meet strict timelines, cross functional communication skills, and critical thinking skills.","Skills":"Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).Experience working in environments requiring large scale retrospective reviews or high volume documentation processing.Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.5+ years of hands-on experience working in a clinical setting, such as a BSN or RN background with direct patient care experience in high-acuity environments including ICU, PCU, ER, or Operating Room units.","Industry":"Administrative Assistant","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":40.0000,"SalaryLow":32.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}
Insight Global is?seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint... remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.Responsibilities:?Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.Work cross functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.Prepare and submit MDRs through the FDA?s electronic submission portal (eMDR) for newly identified reportable events.Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Apr 07, 2026
Durham, NC
|
QA
|
Contract
|
$36 - $45 (hourly estimate)
{"JobID":515947,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-78.91,"Longitude":35.98,"Distance":null},"State":"North Carolina","Zip":"27703","ReferenceID":"RAL-214e3725-dd00-4b0c-9ee7-3e3d6a085129","PostedDate":"\/Date(1775577724000)\/","Description":"Insight Global\u0027s customer is seeking a mid-level Test Engineer to join a growing team responsible for testing software that controls robotic medical devices in Durham, NC. This role will require coming onsite 2-3 days each week.This role was created to support new projects and reduce current testing bottlenecks as development efforts continue to scale. You?ll work closely with software engineers and QA leadership to ensure high-quality, reliable software in a highly regulated, patient-impacting environment. The work is hands-on and detail-oriented, combining manual testing, system setup, and physical device interaction, with a gradual transition toward test automation.Responsibilities:? Develop detailed test plans, scenarios, and scripts.? Execute, analyze, and document test results.? Troubleshoot issues and collaborate with developers on corrective actions.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Software Test Engineer (Raleigh, NC)","City":"Durham","ExpirationDate":null,"PriorityOrder":0,"Requirements":"- 3?5 years of experience in software testing and quality assurance- Bachelor?s degree in Computer Science, Engineering, Mathematics, or a related field - Strong manual testing background- Basic scripting knowledge (not developer-level) withPython, Java, Shell, csharp, or similar- Familiarity with automation concepts and tools (e.g., Selenium, AccelQ, TestComplete)- Solid understanding of testing fundamentals, including: What to test and why, Test completeness, Quality-focused thinking- Experience creating and executing test cases, test plans and test scenarios- Familiarity with defect tracking and test management tools (ADO, Jira, AccelQ, or similar)- Strong troubleshooting and problem-solving skills- Ability to work independently and manage testing responsibilities end-to-end- Excellent attention to detail and documentation skills","Skills":"?Experience testing hardware/device-integrated software?Medical device, regulated industry, or validation testing experience","Industry":"QA","Country":"US","Division":"IT","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":45.0000,"SalaryLow":36.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}
Insight Global's customer is seeking a mid-level Test Engineer to join a growing team responsible for testing software that controls robotic medical devices in Durham, NC. This role will require... coming onsite 2-3 days each week.This role was created to support new projects and reduce current testing bottlenecks as development efforts continue to scale. You?ll work closely with software engineers and QA leadership to ensure high-quality, reliable software in a highly regulated, patient-impacting environment. The work is hands-on and detail-oriented, combining manual testing, system setup, and physical device interaction, with a gradual transition toward test automation.Responsibilities:? Develop detailed test plans, scenarios, and scripts.? Execute, analyze, and document test results.? Troubleshoot issues and collaborate with developers on corrective actions.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Mar 23, 2026
Louisville, CO
|
Electrical Engineering
|
Perm
|
$150k - $170k (estimate)
{"JobID":509874,"JobType":["Perm"],"EmployerID":null,"Location":{"Latitude":-105.14,"Longitude":39.96,"Distance":null},"State":"Colorado","Zip":"80027","ReferenceID":"BOS-5f8c5f26-f674-4ee8-bd5c-64ed34f197d2","PostedDate":"\/Date(1774295112000)\/","Description":"Job Summary:Driven by our purpose to enable healthier lives everywhere, every day, we are seeking a talented and experienced Electrical Engineer to join a growing R\u0026D department in our Surgical Division to contribute to new product development of both Capital and Disposable products. Our team is customer focused, working to enhance the user\u0027s experience through improving our system\u0027s performance, compliance and reliability through state of art hardware design and selection, robust testing, and analysis. In this role you will have the opportunity of working cross functionally with groups such as Quality, Regulatory, and Manufacturing as part of the development cycle.The Lead Electrical Engineer, NPD, delivers value by driving the design and selection of HW that meets the needs of both the customer and the business. This role will be responsible for prototyping, analyzing, and documenting design concepts throughout the NPD cycle. As such, this role requires robust familiarity with design and troubleshooting tools. This role will also support senior level EEs in the design and development of PCBs for control of various subsystems within our capital portfolio. As such, this role will be a champion for state-of-art design practices, including robust design reviews. The Lead Electrical Engineer has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Determines methods and procedures on new assignments and coordinate activities of other personnel as a Team Lead.Essential Duties and Responsibilities: ?Functions as a technical lead for the electrical engineering discipline and can effectively coordinate and contribute to simultaneous programs or projects of varying sizes. ?Participates in product and cross functional product and project teams. ?Represents Electrical Engineering and department culture through example, leadership and excellent communication skills. ?Owns architectural specifications of electrical and electronic systems and subsystems for medical device development. ?Performs and guides lower-level engineers in electrical design, design reviews, and design for manufacturability.?Specifies, evaluates, and selects electronic and electro-mechanical components to meet product specifications. ?Leads design responsibilities such as design, analysis or trouble shooting of printed circuit assemblies, cable and harnessing design, power conversion circuits, analog conversion, filtering circuits, power distribution, and developing CAD schematics for electrical assembly or PCB design. ?Develops, builds, and maintains electrical test fixtures, test control apparatus and equipment to support the development process.?Develops methods of verification of electrical components, PCBs, and subsystems.?Drives a culture of continuous learning and improvement. Champions opportunities to introduce new technologies, systems, methods, and controls and deliver design, quality, cost or time-to-market improvements. ?Works with contract manufacturers and vendors/suppliers to ensure device design and parts meet functionality and medical device quality and regulatory standards. ?Establishes collaborative relationships with all stakeholders within the division and create links with experts within the Hologic network and outside.?Stays current with emerging technologies and processes to support ongoing innovation. ?Trains and mentors lower-level engineers to further develop and impact the organization. Compensation: $150,000 to $170,000. Exact compensation may vary based on several factors, including skills, experience, and education.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Lead Electrical Engineer, New Product Development","City":"Louisville","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Qualifications and Experience:?Bachelor?s or Master?s in Electrical Engineering?8+ Years of work experience in new product development and/or the medical device industry with Bachelor?s Degree?6+ Years of work experience in new product development and/or the medical device industry with Master?s DegreeSkills:?Advanced schematic-level design experience, preferably experience using the Altium toolset.?Expert experience in use of common electrical test and development equipment such as oscilloscopes, LCR meters, logic analyzers, and power supplies.?In-depth knowledge of electronic design, medical device design, analog/digital circuit design, PCB design, PCB and PCBA manufacturing processes. ?Experience with FPGAs and/or CPLDs.?Sensor integration??Knowledge of radiofrequency energy generation and control preferred.?Experience with analog and digital circuits, including microcontrollers.?Foundational understanding of design for IEC 60601-1, 60601-1-2, and 60601-2-2.?Ability to trouble shoot and root cause failure modes associated with PCBs.?Experience in the medical device industry.?Preferred clinical and technical knowledge within the field of gynecological surgery, or an applicable surgical space or technology.?Demonstrated ability to think strategically about products and effectively guide decisions related to product risks and opportunities.?Knowledge and experience across engineering disciplines. Familiarity of embedded systems with ability to collaborate between hardware and software working groups.?Ability to analyze a situation or data; evaluate relevant identifiable factors and translate information into a meaningful proposal or action plan.?Excellent written, verbal, and interpersonal skills. Adapts communication style to suit different audiences. Creates precise, accurate technical documentation. Able to facilitate brainstorming, Root Cause, Root Cause Failure Analysis Methodologies, and other group discussions. Travel:Ability to travel as necessary up to 10%.","Skills":"","Industry":"Electrical Engineering","Country":"US","Division":"IT","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":170000.0000,"SalaryLow":150000.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}
Job Summary:Driven by our purpose to enable healthier lives everywhere, every day, we are seeking a talented and experienced Electrical Engineer to join a growing R&D department in our Surgical... Division to contribute to new product development of both Capital and Disposable products. Our team is customer focused, working to enhance the user's experience through improving our system's performance, compliance and reliability through state of art hardware design and selection, robust testing, and analysis. In this role you will have the opportunity of working cross functionally with groups such as Quality, Regulatory, and Manufacturing as part of the development cycle.The Lead Electrical Engineer, NPD, delivers value by driving the design and selection of HW that meets the needs of both the customer and the business. This role will be responsible for prototyping, analyzing, and documenting design concepts throughout the NPD cycle. As such, this role requires robust familiarity with design and troubleshooting tools. This role will also support senior level EEs in the design and development of PCBs for control of various subsystems within our capital portfolio. As such, this role will be a champion for state-of-art design practices, including robust design reviews. The Lead Electrical Engineer has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Determines methods and procedures on new assignments and coordinate activities of other personnel as a Team Lead.Essential Duties and Responsibilities: ?Functions as a technical lead for the electrical engineering discipline and can effectively coordinate and contribute to simultaneous programs or projects of varying sizes. ?Participates in product and cross functional product and project teams. ?Represents Electrical Engineering and department culture through example, leadership and excellent communication skills. ?Owns architectural specifications of electrical and electronic systems and subsystems for medical device development. ?Performs and guides lower-level engineers in electrical design, design reviews, and design for manufacturability.?Specifies, evaluates, and selects electronic and electro-mechanical components to meet product specifications. ?Leads design responsibilities such as design, analysis or trouble shooting of printed circuit assemblies, cable and harnessing design, power conversion circuits, analog conversion, filtering circuits, power distribution, and developing CAD schematics for electrical assembly or PCB design. ?Develops, builds, and maintains electrical test fixtures, test control apparatus and equipment to support the development process.?Develops methods of verification of electrical components, PCBs, and subsystems.?Drives a culture of continuous learning and improvement. Champions opportunities to introduce new technologies, systems, methods, and controls and deliver design, quality, cost or time-to-market improvements. ?Works with contract manufacturers and vendors/suppliers to ensure device design and parts meet functionality and medical device quality and regulatory standards. ?Establishes collaborative relationships with all stakeholders within the division and create links with experts within the Hologic network and outside.?Stays current with emerging technologies and processes to support ongoing innovation. ?Trains and mentors lower-level engineers to further develop and impact the organization. Compensation: $150,000 to $170,000. Exact compensation may vary based on several factors, including skills, experience, and education.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Apr 08, 2026
Arden Hills, MN
|
Engineering (Non IT)
|
Contract,Perm Possible
|
$38 - $48 (hourly estimate)
{"JobID":516609,"JobType":["Contract,Perm Possible"],"EmployerID":null,"Location":{"Latitude":-93.1,"Longitude":44.94,"Distance":null},"State":"Minnesota","Zip":"55112","ReferenceID":"MSP-68cea85b-5722-44f1-a8b7-060ea9f8caeb","PostedDate":"\/Date(1775671733000)\/","Description":"Insight Global is seeking a Quality Engineer to support a leading medical device manufacturer?s Cardiology division, focused on identifying actionable root causes and implementing effective solutions for high-visibility issues impacting Active Implantable and Accessories product performance. This role is ideal for a technically curious engineer looking to build leadership, complex problem-solving, and project management experience while leading cross-functional investigations into design-related product performance issues, including NCEPs, CAPAs, and potential field actions. The Quality Engineer will collaborate closely with Research \u0026 Development, Regulatory, Manufacturing, Medical Safety, Marketing, Post-Market, and other Quality teams, leveraging structured problem-solving methodologies to drive compliant, well-documented outcomes, support risk management, new product development, and sustainment activities, and uphold the highest standards of patient safety and product quality.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Quality Engineer","City":"Arden Hills","ExpirationDate":null,"PriorityOrder":0,"Requirements":"- Bachelor\u0027s degree in engineering (ideally systems or electrical engineering)- 4+ years of experience as an engineer? Background as Systems Engineer or Electrical Engineer helpful - Experience with CAPAs, field action decision making and other investigation processes - Medical Device industry experience","Skills":"- Experience with Active Implantable medical technologies- Experience with statistics and statistical analysis tools (e.g. MINITAB, Weibull++)- Strong ability to successfully multi-task and demonstrate adaptability - Project management experience (direct or cross-functional teams)- Strong business acumen and communication skills, with the ability to quickly establish impact and consequences- Ability to collaborate and influence across multiple, cross-functional teams Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions.","Industry":"Engineering (Non IT)","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":48.0000,"SalaryLow":38.4000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}
Insight Global is seeking a Quality Engineer to support a leading medical device manufacturer?s Cardiology division, focused on identifying actionable root causes and implementing effective solutions... for high-visibility issues impacting Active Implantable and Accessories product performance. This role is ideal for a technically curious engineer looking to build leadership, complex problem-solving, and project management experience while leading cross-functional investigations into design-related product performance issues, including NCEPs, CAPAs, and potential field actions. The Quality Engineer will collaborate closely with Research & Development, Regulatory, Manufacturing, Medical Safety, Marketing, Post-Market, and other Quality teams, leveraging structured problem-solving methodologies to drive compliant, well-documented outcomes, support risk management, new product development, and sustainment activities, and uphold the highest standards of patient safety and product quality.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Mar 16, 2026
Blue Ash, OH
|
Engineering (Non IT)
|
Contract
|
$52 - $65 (hourly estimate)
{"JobID":506878,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-84.51,"Longitude":39.09,"Distance":null},"State":"Ohio","Zip":"45242","ReferenceID":"CIN-60b4c03a-2b82-4a3e-b6f0-ff64c224b4e8","PostedDate":"\/Date(1773672715000)\/","Description":"An employer is seeking Senior Equipment Process Engineer to support New Product Development (NPD) and manufacturing scale-up of medical devices in a regulated environment. This role will be long term and located in the Blue Ash, OH area. The equipment process engineer will be responsible for the development, qualification, and optimization of custom manufacturing equipment and processes that meet stringent quality, reliability, and regulatory requirements. The ideal candidate brings deep expertise in equipment-centric process development, supplier collaboration, and material-sensitive manufacturing processes, with a strong understanding of FDA and ISO expectations.The core responsibilities will include:-Develop and refine New Product Development (NPD) processes in compliance with FDA, ISO 13485, and internal quality system requirements.-Partner with equipment suppliers to design, build, and qualify new manufacturing equipment and process solutions.-Lead process characterization activities to identify and optimize Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).-Design and execute Design of Experiments (DOE); perform statistical analysis and establish process capability (Cp/Cpk, Pp/Ppk).-Define and implement process control limits, control plans, and monitoring strategies to ensure sustained process performance.-Plan and execute Measurement System Analysis (MSA) and Gage R\u0026R studies to validate measurement methods.-Provide hands-on technical support during equipment development, FAT/SAT, installation, qualification, validation, and production ramp-up.-Qualify and validate PLC-controlled software systems; troubleshoot issues, document changes, and support software fixes.-Collaborate cross-functionally with R\u0026D, Manufacturing, Quality, and Supply Chain to drive compliant, scalable solutions to market.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.","Title":"Equipment Process Engineer","City":"Blue Ash","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Bachelor?s degree in Engineering (Mechanical, Electrical, Manufacturing, Chemical, or related).Experience in medical device, pharmaceutical, or other highly regulated manufacturing environments.Strong knowledge of GMPs, validation methodologies, and equipment lifecycle management.3+ years developing custom sterile barrier packaging and boxing equipment and processes (foil-based, bioabsorbable, and moisture-sensitive materials)Hands-on experience with vacuum drying equipment and associated process development and validation.Proven ability to manage external equipment suppliers through design, build, and qualification phases in a regulated environment.Ability to travel domestically once a month to supplier sites","Skills":"medical device certifications","Industry":"Engineering (Non IT)","Country":"US","Division":"AF\u0026E","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":65.0000,"SalaryLow":52.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}
An employer is seeking Senior Equipment Process Engineer to support New Product Development (NPD) and manufacturing scale-up of medical devices in a regulated environment. This role will be long term... and located in the Blue Ash, OH area. The equipment process engineer will be responsible for the development, qualification, and optimization of custom manufacturing equipment and processes that meet stringent quality, reliability, and regulatory requirements. The ideal candidate brings deep expertise in equipment-centric process development, supplier collaboration, and material-sensitive manufacturing processes, with a strong understanding of FDA and ISO expectations.The core responsibilities will include:-Develop and refine New Product Development (NPD) processes in compliance with FDA, ISO 13485, and internal quality system requirements.-Partner with equipment suppliers to design, build, and qualify new manufacturing equipment and process solutions.-Lead process characterization activities to identify and optimize Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).-Design and execute Design of Experiments (DOE); perform statistical analysis and establish process capability (Cp/Cpk, Pp/Ppk).-Define and implement process control limits, control plans, and monitoring strategies to ensure sustained process performance.-Plan and execute Measurement System Analysis (MSA) and Gage R&R studies to validate measurement methods.-Provide hands-on technical support during equipment development, FAT/SAT, installation, qualification, validation, and production ramp-up.-Qualify and validate PLC-controlled software systems; troubleshoot issues, document changes, and support software fixes.-Collaborate cross-functionally with R&D, Manufacturing, Quality, and Supply Chain to drive compliant, scalable solutions to market.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.