Job Search Results for medical device regulations

A client of insight Global is looking for a Medical Device and IoMT Security Specialist to join their team. This person will be helping to set up a greenfield cybersecurity program for connected... More medical/IoMT devices within the company aligning with Clinical Engineering/Healthcare Technology Management (HTM) and IT.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

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

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

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

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

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

The Mechanical Project Development Engineer is responsible for designing and developing complex medical device components by translating engineering requirements into high-quality, compliant design... More solutions with limited supervision. This role defines and executes test and validation activities, resolves advanced technical issues to ensure reliable production, and evaluates external components and technologies to meet quality, performance, and regulatory standards. Key Responsibilities: ? Designs and develops mechanical components and assemblies for medical devices by translating engineering requirements into robust, manufacturable design solutions with minimal supervision.? Troubleshoots and resolves complex mechanical and system-level issues, working cross-functionally to prevent production delays and improve product durability and reliability.? Evaluates and selects mechanical components, materials, and suppliers, ensuring designs meet performance, manufacturability, and cost objectives.? Communicates mechanical design progress and technical findings clearly, supports junior engineers, and applies mechanical engineering best practices to improve processes, product performance, and time to market.? Develops and executes mechanical test plans and validation activities to verify performance, reliability, and compliance with quality and regulatory requirements.Support and execute Corrective and Preventive Actions (CAPA) functions within an R&D product/process scope.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