Job Search Results for Medical device

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... More 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/.Less

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... More 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/.Less

? Manage RST RPM/E (release project management/engineering) portfolio CAPAs, ensuring triage, prioritization, timelines, and escalation? Implement and maintain a CAPA tracking workflow? Monitor due... More dates, milestones, and provide weekly/monthly reporting? Forecast resources and funding for CAPA investigations? Identify emerging risks or future CAPAs using metrics, audits, and trend signals? Support project planning, scheduling, risk management, and communication? Participate in SAFe ceremonies, reporting, and continuous improvement efforts? Partner cross-functionally with Quality, RPE Product Engineering, RPE ITI, and Scrum teamsInsight Global is seeking a CAPA Program Manager to support a top medical device client within their RST RPM/E organization. This consultant will manage and mature the CAPA process across multiple value streams, ensuring efficient intake, tracking, reporting, and cross-functional alignment. The ideal candidate brings medical device CAPA experience, strong project management capabilities, exceptional attention to detail, and comfort working within Agile (preferably SAFe) environments. This role is highly visible, working closely with engineering, quality, and leadership teams to drive quality execution and continuous improvement initiatives.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/.Less

An employer is seeking a Field Data Engineer for a long term opportunity in the Cincinnati, OH area. This Data Engineer will be tied to multiple NPD projects for a medical device leader and will... More report into the Data Lead over the program. The Field Data Engineer will be required to establish consistency, structure, and scalability across how data is collected, stored, processed, and prepared for deeper analytics. This individual will own the end-to-end data lifecycle for field and test data, driving standardization and enabling reliable downstream analysis. While this is an individual contributor role, it requires strong leadership, initiative, and the ability to independently prioritize work across multiple stakeholders as the stakeholders they will be working with are mechanical and test engineers. Ideally someone with 2+ years in a testing role will be the correct fit for this role. The main responsibilities will include:Data Collection - establish and enforce data collection norms, streamline existing collection processes and participate in data collection. This will be performed utilizing python, git, SQL or other data engineering toolsData Storage: compile, clean, organize, and develop data pipelines and database schemas coming from ~10 collective test stands, including offline equipment. They will also support data transfers via USB and other offline methods, ensuring integrity and traceabilityWe 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/.Less

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... More 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/.Less

A large medical device company in Irvine, CA is looking for a Product Stewardship Engineer to support material compliance and regulatory activities for critical care medical devices. This individual... More will support product stewardship efforts across the product lifecycle, including material compliance, restricted substance tracking, BOM review, and regulatory documentation. The role will work closely with R&D, Engineering, Quality, Regulatory, and Supply Chain teams to ensure products meet global material and environmental regulations.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/.Less

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... More 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/.Less

An employer is looking for a Proposal Specialist/Business Representative to join their lab located in Midland, MI. This individual will join a team that writes proposals for chemistry focused studies... More for the following disciplines: consumer products, medical device, pharmaceuticals, specialty chemistry and bioanalytical. A request will come through the website/email and this person will meet with the client to gather specific specs that they are looking to uncover in the study. Then, you will either connect with the lab analyst to discuss how they would conduct the study or use your prior chemistry knowledge to write a proposal for how the study would be conducted. You will also include pricing in the proposal. Once the client accepts the proposal, the lab will begin working on the study. When the lab delivers the study to the client, you will be paid commission for the deal. You could work on anywhere from three to twelve proposals in a day depending on your experience level and the complexity of the proposal. We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. 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/ .Less

This role is responsible for executing validation and quality activities required for the introduction and delivery of a new Hinge cast product line, as well as supporting EU MDR validation... More assessment and rationalization. The position operates in a highly regulated medical device manufacturing environment and requires strong expertise in process validation, quality systems, and change control. The successful candidate is a proactive self-starter who collaborates effectively across cross-functional teams to ensure compliance with global regulatory requirements.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/.Less

Insight Global is seeking an Operations Manager (1st Shift) to support a medical device manufacturing operation in Norwood, MA. This is a full-time, onsite leadership role responsible for overseeing... More first-shift operations across two manufacturing buildings and leading a high-performing operations team.Day-to-Day Responsibilities-Lead and motivate manufacturing teams across two facilities, fostering a culture of accountability, collaboration, and continuous improvement.-Manage daily production output, quality performance, shop floor controls, and task assignments.-Partner with planning, production supervisors, and engineering to manage day-to-day production activities.-Implement and maintain manufacturing process controls and quality standards to ensure compliance with customer, GMP, and ISO 13485 requirements.-Drive strategies to scale manufacturing operations in support of future growth.-Conduct resource planning and proactively identify staffing, equipment, and capability gaps.-Coach, mentor, and develop supervisors, leads, and production associates, including onboarding and performance development.-Establish and lead Lean manufacturing initiatives, including daily standups, Gemba walks, and continuous improvement projects.-Identify and implement process improvements to increase efficiency and reduce costs.-Collaborate with senior leadership and HR on hiring needs, training requirements, and workforce planning.-Ensure compliance with Quality, EHS, and OSHA requirements, policies, and procedures.-Establish departmental goals, track KPIs, manage budgets, and oversee departmental expenses.-Support performance management activities, including feedback, disciplinary actions, promotions, and performance reviews.-Perform other related duties as assigned.Compensation:$140,000 - $150,000 per year (annual salary)Exact compensation may vary based on 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/.Less