Job Search Results for medical device regulations

A global medical technology organization specializing in advanced patient monitoring and life-sustaining devices is seeking a Program Manager to lead complex product transition and commercialization... More initiatives within a regulated New Product Development (NPD) environment. This role will support the integration and rebranding of existing cardiovascular monitoring platforms following a large organizational transition, requiring coordination across hardware, software/firmware, manufacturing, quality, and commercial teams. The Program Manager will drive execution across cross-functional stakeholders to ensure successful product readiness and on-time commercialization, managing program timelines, risk, and alignment within established design control and quality system processes. The ideal candidate brings experience managing medical devices that combine physical hardware with embedded software or firmware components and can effectively partner with engineering teams to navigate system integration, manufacturing updates, and product lifecycle execution within a highly matrixed environment.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

We are looking for a skilled Innovation engineer to join our team! This Innovation Engineer is a professional who creates and implements new ideas, technologies, and processes to improve existing... More products or develop entirely new solutions, this role will be within the medical device division. By combining technical expertise with creative problem-solving, they generate innovative concepts, conduct research and experimentation, build and test prototypes, and oversee implementation. Working closely with cross-functional teams such as designers, marketers, and engineers, Innovation Engineers help organizations adapt to changing market demands, solve complex challenges, and remain competitive through continuous innovation.Locations: - Brooklyn Park, MN- Westborough, MA Compensation:$50-60/hr Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off 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 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

We?re supporting a fast-growing, mission-driven medical device company in the diabetes technology space that is seeking an experienced Design Verification (DV) Test Technician to support hands-on lab... More testing in a highly regulated environment. This person will work closely with engineers to execute mechanical performance testing for hardware components, following established test protocols and accurately documenting results. The role is heavily lab-based and focused on running verification and performance tests, maintaining lab equipment, managing test samples, and ensuring all work is completed in accordance with regulatory and documentation standards. This is not an assembly role - it requires strong mechanical intuition, attention to detail, and the ability to follow structured procedures precisely in support of product development efforts.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

Seeking experienced Sr. Quality Engineers to join the Risk Management team for a leading medical device organization. These roles will focus on risk analysis, document maintenance, and supporting... More design changes and sustaining activities.Key Responsibilities?Own and maintain risk documentation (PFMEAs, risk files) across multiple product lines.?Perform risk analysis including FMEA, risk management matrices, and safety risk assessments.?Support sustaining engineering activities, including design changes and corrective actions for field issues.?Ensure compliance with ISO 13485 and ISO 14971 standards.?Collaborate cross-functionally to articulate risk management strategies during audits.?Assist in remediation and updates of high-volume risk files (top-level: ~30; low-level: hundreds).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 Sr. Mechanical Engineer to join their Research + Development team in support of a remediation project. The ideal resource will have a strong... More mechanical engineering background with specific experience working with Solidworks CAD software, developing test methodologies, and running the design verification process. Day to day activities will include developing test methodology as the team moves into the execution portion of their remediation project and involves interfacing with Technicians and DQA Engineers. The role will be a 5-month contract with possible extensions until integration work is concluded and hybrid 3 days per week in Valencia, CA requiring the resource to be onsite in their machine shop with the R+D team.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

As a Software Test Engineer within our organization, you will play a critical role in verifying software for a groundbreaking robotic surgical platform. This role is highly hands-on and... More domain-driven, requiring deep understanding of complex hardware, embedded systems, and how software interacts with physical devices in a regulated medical environment.This position is ideal for someone with strong manual testing expertise, true medical device or robotics domain knowledge, and experience working at the intersection of hardware, firmware, networking, and software.?Execute manual test cases, test scripts, and formal verification protocols across functional, integration, and system-level testing?Install software on robotic surgical platforms and perform testing on release builds?Perform ad hoc and exploratory testing during development cycles, including defect verification and regression testing?Create, update, and maintain detailed test documentation, scripts, and execution records following formal design verification practices?Work closely with software, firmware, and hardware engineering teams to identify, troubleshoot, and resolve defects?Validate end-to-end workflows involving hardware?software interfacing and device-to-device communication?Support system qualification, instrument qualification, and equivalency testing as required?Use defect tracking and requirements tools to trace coverage and ensure compliance with regulatory expectationsWe 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 Senior Electrical Engineer to join a leading medical device manufacturer?s Cardiology team, supporting sustaining work on pacemakers. This role involves designing,... More prototyping, testing, and troubleshooting electronic components and systems, as well as setting up and executing electrical tests to ensure accurate and reliable data collection. Responsibilities include performing bench-level and design verification testing to validate product performance, analyzing results, and providing feedback to improve functionality. The engineer will collaborate with cross-functional teams to refine specifications, resolve issues with prototypes and existing products, and document test procedures, results, and design changes in compliance with regulatory standards. Additional duties include preparing technical reports and presentations for stakeholders while maintaining a strong commitment to quality and patient safety.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