Job Search Results for medical device regulations

Insight Global is hiring a Quality Engineer for our medical device client in Danvers, MA. This role will onsite 5 days per week.Day-to-Day-Provide quality support for service and repair operations,... More including nonconformances, CAPAs, change controls, and escalations-Partner with operations teams to ensure compliance with medical device quality systems and regulatory requirements-Support internal and external audits and inspections related to service and repair activities-Help implement and improve quality processes, SOPs, and systems aligned with industry standards-Identify quality risks, support issue resolution, and drive continuous improvement initiatives-Collaborate cross-functionally with quality, operations, supply chain, and commercial teamsCompensation: $45.00/hr to $50.00/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

Medical Device client is seeking a Design Assurance Engineer (R&D Engineer) to support multiple critical projects with upcoming submission deadlines over the next three months. This individual will... More play a key role in driving project execution and ensuring timely completion of deliverables, with primary project timelines targeted for completion by the end of August. This is a fast-paced role requiring strong multitasking capabilities, adaptability, and the ability to quickly ramp on new tasks.Key Responsibilities?Support multiple concurrent projects with aggressive timelines, ensuring milestones and deliverables are completed on schedule?Execute and support thermal testing and tablet hardware testing (training will be provided if needed)?Develop, review, and execute test protocols and reports in alignment with medical device standards?Support design assurance activities for an implantable medical device system (epilepsy-focused technologies)?Contribute to documentation aligned with medical device regulatory requirements?Review and support activities related to system-level components, including batching and tablet-based system integration?Collaborate cross-functionally with: oR&D EngineersoManufacturing EngineersoProject Managers?Effectively manage and prioritize multiple tasks simultaneously while maintaining quality and compliance standardsWe 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 Quality Engineer to support a leading medical device manufacturer specializing in combination medical devices. This newly created role is focused on establishing a... More best-in-class approach to drug?device combination products, integrating pharmaceutical science, quality systems, and manufacturing execution. The ideal candidate will have a science-based background?such as pharmaceutical, chemistry, or combination product experience?and the ability to apply those principles within a medical device manufacturing environment.This role provides quality and process engineering support to product development teams within Urology and Cardiology, with responsibility for reducing manufacturing defects by leading root cause analysis and implementing effective corrective and preventive actions. You will develop and maintain product and process quality documentation, including specifications, risk assessments, and FMEAs, while establishing process monitoring systems to reduce variation and eliminate defect sources. The role also involves analyzing manufacturing quality data to drive continuous improvement, creating quality tools and training materials, and ensuring compliance with regulatory and company requirements. As the technical lead for combination products under 21 CFR Part 4, you will support audits, perform trend analysis, oversee corrective actions, and approve final process monitor releases prior to distribution.This position is fully onsite in Arden Hills, MN, and offers a salary range of $100,000?$125,000 plus a 10% bonus, depending on experience.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 hiring a Quality Engineer for our medical device client in Danvers, MA. This role will onsite 5 days per week.Day-to-Day-Provide quality support for service and repair operations,... More including nonconformances, CAPAs, change controls, and escalations-Partner with operations teams to ensure compliance with medical device quality systems and regulatory requirements-Support internal and external audits and inspections related to service and repair activities-Help implement and improve quality processes, SOPs, and systems aligned with industry standards-Identify quality risks, support issue resolution, and drive continuous improvement initiatives-Collaborate cross-functionally with quality, operations, supply chain, and commercial teamsCompensation: $45.00/hr to $50.00/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

One of our large Medical Device companies is seeking a highly qualified Senior HMI Development & Integration Engineer to support the design, development, deployment, and sustainment of Human-Machine... More Interface systems utilized in the production of medical device products. The selected engineer will lead HMI development initiatives across a multi-vendor machine platform, drive standardization of HMI architectures on-site, and provide technical leadership throughout the full project lifecycle. This role is primarily focused on HMI system design, cross-vendor integration, and technical documentation in support of validation and qualification activities ? requiring advanced proficiency in HMI engineering execution, SCADA platforms, and regulated environment documentation practices. The engineer will be responsible for leading the design, development, programming, and documentation of HMI solutions across a multi-vendor manufacturing system comprised of three distinct vendor platforms. The candidate will serve as the primary HMI technical authority, responsible for harmonizing vendor-specific HMI standards into a unified, site-compliant solution. All work will be performed within a medical device regulated environment and must adhere to applicable internal procedures, GAMP 5, and GxP standards.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 global medical device manufacturing organization is seeking a Production Operator ? Console / Electromechanical Assembly to support the build and assembly of medical device console systems at its... More Bedford, MA facility. This role focuses on lower-volume, more technical assembly work, including electromechanical components, electronic boards, and integrated systems.The ideal candidate has strong technical aptitude, is comfortable working in a regulated cleanroom production environment, and has experience assembling complex mechanical or electronic components.This position supports production ramp-up and long-term stabilization of 2026 manufacturing volume.Compensation: $28/hr. to $30/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on day one 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 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

Insight Global is seeking a E2E supply chain planner to join a large medical device company local to Irvine, CA.We are a company committed to creating diverse and inclusive environments where people... More 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 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