Job Search Results for medical device regulations

Insight Global is seeking a Mechanical Test Engineer for a top medical device client. This engineer will support verification efforts for a syringe-delivered gel product focused on female urinary... More incontinence. The role involves adapting and developing mechanical test methods, validating test procedures, training technicians, and analyzing mechanical performance data. The ideal candidate is highly hands-on with mechanical testing equipment, comfortable working in a regulated environment, and capable of producing strong technical documentation. This engineer will collaborate cross-functionally to ensure complete verification coverage and maintain high-quality test method traceability.Day-to-Day:Review and adapt existing Boston Scientific test methods for new componentsDevelop, modify, and document procedures for mechanical testing (volume displacement, tensile, torque, etc.)Lead test method validation and train/coach techniciansCoordinate technician scheduling and manage daily test execution activitiesPerform statistical data analysis in Minitab and prepare test reportsOperate and specify mechanical test equipment (MTS systems, torque gauges)Partner with chemical/test engineers to ensure complete verification coverageMaintain documentation, data files, and test traceabilityEnsure alignment with quality processes and escalate technical judgment calls when appropriateWe 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

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 a qualified Product Complaints Technician to join an established medical device company in Mundelein, IL. This individual will be responsible for a large-scale remediation... More project. Their responsibilities will include a full review of cause and defect codes during complaint investigations, and addressing reportability and correcting major systemic issues.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 client in the medical device industry is seeking a QA Internal Auditor to join their Quality department. This role will own the full audit lifecycle including developing audit plans, conducting... More internal audits, assisting with external audits, documenting findings and driving corrective actions through to closure. This resource will evaluate quality systems against ISO 13485 and regulatory requirements, identify gaps, and partner with cross-functional teams to improve processes and ensure compliance. They will also support external audits with regulatory bodies, communicate audit results to leadership, and track remediation efforts. This is a full-time permanent position with a hybrid schedule, expected to be 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 Product Complaints Technician to join an established medical device company in Mundelein, IL. This individual will be responsible for a large-scale remediation... More project. Their responsibilities will include a full review of cause and defect codes during complaint investigations, and addressing reportability and correcting major systemic issues.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

The Senior Product Manager, Global Downstream Marketing ? Endoscopic Ultrasound (EUS) leads U.S. downstream marketing strategy and execution across the established EUS needles portfolio and new,... More early-stage technologies. The role is responsible for balancing near-term commercial execution with long-term market development and launch excellence.This position partners cross-functionally with Sales, Clinical, Professional Education, Manufacturing, Supply Chain, and other stakeholders while maintaining deep engagement with physicians and Key Opinion Leaders. The role is highly commercial, field-facing, and execution-driven, operating within a regulated medical device environment.Day-to-Day Responsibilities? Commercial execution and portfolio growth? Pricing and training strategy? Global expansion support? Content alignment and development? Heavy physician engagement? Close partnership with Sales? Approximately 40% field travelCompensation: $155,000 per year annual salary. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role include: [description should be provided by the client since this is for a perm position- they will not receive IG benefits. If client does not provide it upon our request, we can insert something generic like "Benefit packages for this role may include healthcare insurance offerings and paid leave as provided by applicable law."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 Labeling Project Manager for a leading medical device client within the orthopaedics space. This individual will play a critical role in implementing a new labeling system... More while driving process harmonization and standardization across global teams. The role combines hands-on project management with cross-functional collaboration across quality, regulatory, IT, and supply chain to ensure compliance and successful system adoption. The ideal candidate brings strong experience in regulated environments, excels at managing complex stakeholder landscapes, and is passionate about improving labeling processes to support high-quality patient outcomes.Compensation: $58/hr to $63/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.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

The Test Method Validation Engineer will lead hands-on development, validation, and execution of test methods used to verify medical device performance, reliability, and safety. This role supports... More design verification and limit/challenge testing activities across active development programs and ensures test methods meet regulatory and engineering standards. The engineer will collaborate closely with Product Development, Quality, and Regulatory teams.Compensation: $45/hr to $55/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.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 ERP Application Engineer to support and improve an ERP system and workflows within a medical device production environment. This role focuses on bridging operations and... More technology by supporting day to day ERP system issues, while leading long term system and continuous improvements. The position partners closely with Operations, Supply Chain, Finance, and IS teams to ensure manufacturing systems effectively support production needs.Key Responsibilities:- Support manufacturing operations by troubleshooting ERP and system-related issues and driving resolutions- Lead or execute system and process improvements to enhance efficiency, reliability, and scalability- Gather and document business and technical requirements, including workflows and functional specifications- Coordinate with cross-functional teams and IS partners to design, test, and implement ERP system enhancements- Assess current processes, identify gaps, and recommend solutions to prevent recurring operational issues within the ERP- Participate in production meetings and support planning and forecasting needs- Help establish and reinforce quality and continuous improvement practices within the ERP system and manufacturing environmentWe 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