Job Search Results for medical device regulations

Insight Global is hiring a Quality Engineer for our medical device client in Danvers, MA. This role is onsite five days per week and will focus on supporting commercial quality distribution and field... More action execution, including active recalls, within a regulated medical device environment.Day-to-Day-Provide quality support for commercial distribution, service, and repair operations, including nonconformances, CAPAs, change controls, and escalations-Support field action and recall execution, including coordination and tracking activities for multiple active field actions over the next six months-Oversee quality activities related to finished goods and materials that are approved and released to distribution warehouses-Partner with operations and supply chain teams to ensure compliance with medical device quality systems and regulatory requirements-Support internal and external audits and inspections related to distribution, service, and field action activities-Help implement and continuously 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 teams to define and execute quality and field action strategiesCompensation: $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

Insight Global is searching for a Senior R&D Engineer III for a leading medical device client. This individual will join an early-stage new product development initiative focused on the design and... More development of a novel single-use medical device that interfaces with capital equipment. The engineer will play a critical role in advancing the product from development through testing, iteration, and implementation while partnering closely with technical leads, product development engineers, quality teams, and external partners. This position requires a highly independent engineer who can take ownership of complex technical challenges, proactively identify solutions, and drive projects forward with minimal direction.Day-to-day responsibilities will include CAD design, hands-on laboratory experimentation, prototype development, design troubleshooting, testing, data analysis, technical documentation, and cross-functional collaboration. The ideal candidate will be comfortable moving between computer-based design work and hands-on engineering activities while owning projects throughout the full product lifecycle. Successful candidates will possess strong technical leadership capabilities, demonstrate sound engineering judgment, and have the ability to mentor others through influence and expertise. This role is approximately 40% experimentation/testing, 40% design, analysis and documentation, and 20% technical leadership, issue resolution, and team collaboration.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

Insight Global is seeking a Quality Inspection Technician for a cutting-edge medical device company focused on improving patient outcomes through innovative healthcare technology. This individual... More will support incoming, in-process, and final inspections of components and assemblies used in the manufacturing of regulated medical devices. The ideal candidate has hands-on quality inspection experience, is comfortable working with precision measurement tools, and enjoys working in a collaborative environment. This role offers the opportunity to work closely with quality, manufacturing, and material planning teams while contributing directly to the production of life-changing healthcare productsDay-to-Day:? Perform incoming inspection of raw materials and purchased components? Inspect off-the-shelf parts, third-party injection molded components, PCBAs, cables, and finished products? Conduct receiving, in-process, and final inspections to ensure products meet specifications ? Utilize calipers, micrometers, pin gauges, height gages, and other quality inspection tools to verify quality standards? Complete inspection documentation and maintain quality records? Support First Article Inspections (FAIs) and non-conformance investigations? Coordinate closely with the Material Planning Team to ensure incoming materials are inspected and released efficiently? Assist with inventory movements, traceability activities, and quality record management ? Support the release of finished wearable medical device products for production and shipmentWe 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 OverviewInsight Global is seeking a Scientist I to support one of our top medical device clients, Boston Scientific, at their Arbor Lakes, MN location. This individual will join a research and... More development team focused on executing laboratory testing, method development, data analysis, and technical documentation in support of new and existing medical device projects.The ideal candidate will have a strong scientific background in Biology, Chemistry, or a related engineering discipline, prior medical device experience, and a hands-on approach to laboratory testing and problem solving. This role is highly collaborative and will require working cross-functionally with scientists and engineers to generate data, support experiments, and contribute to project deliverables.Note: PhD candidates will not be considered for this opportunity.Day-to-Day Responsibilities? Execute laboratory experiments, testing protocols, and routine scientific procedures under limited supervision? Support test method development and validation activities? Analyze experimental data, identify trends, and compare findings to historical data? Maintain detailed laboratory documentation including notebooks, reports, and technical records? Generate data summaries and contribute to technical reports, presentations, and project documentation? Assist with Design of Experiments (DOE) execution and statistical analysis activities? Collaborate with cross-functional R&D teams to support project goals and timelines? Support equipment maintenance, calibration, and qualification efforts as needed? Order laboratory supplies and support inventory management activities? Follow all quality, safety, and regulatory requirements while maintaining a clean and organized laboratory 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

A large medical device company is seeking a Clinical Research Manager to support the planning, execution, and oversight of global clinical studies. This individual will be responsible for managing... More clinical trial activities to support the development, regulatory approval, and commercialization of innovative cardiac ablation technologies and electrophysiology products.The ideal candidate will have a minimum of 3 years of experience managing clinical trials within the medical device, biotechnology, pharmaceutical, or healthcare industry and possess a thorough understanding of Good Clinical Practice (GCP), FDA regulations, ISO 14155, and global clinical research requirements.Key ResponsibilitiesLead the day-to-day management of clinical studies for electrophysiology medical devices from study startup through closeout.Develop and maintain study timelines, budgets, risk mitigation plans, and project tracking tools.Collaborate with cross-functional teams including Clinical Affairs, Regulatory Affairs, Quality, R&D, Biostatistics, Data Management, and Medical Affairs.Manage relationships with clinical investigators, research sites, contract research organizations (CROs), and external vendors.Monitor study progress, enrollment metrics, protocol compliance, and data quality.Ensure clinical studies are conducted in compliance with:FDA regulations (21 CFR Parts 11, 50, 54, 56, 812)ICH-GCP GuidelinesISO 14155Company SOPs and regulatory requirementsKey responsibilities:Review and contribute to study protocols, informed consent forms, case report forms, monitoring plans, and clinical study reports.Support adverse event reporting and clinical safety surveillance activities.Oversee clinical trial documentation including Trial Master File (TMF) management and inspection readiness activities.Participate in regulatory submissions, audits, and inspections.Analyze study performance metrics and provide status reports to senior leadership.Support publications, abstracts, investigator meetings, and scientific presentations related to clinical studies.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's client is seeking a Senior Electrical Engineer to serve as a key technical leader supporting the development and manufacturing of medical and healthcare-related products within a... More global manufacturing environment. This individual will act as the primary electrical engineering resource between U.S.-based customers and offshore manufacturing teams, ensuring products are successfully developed, transferred, and manufactured to quality, cost, and performance expectations.The ideal candidate combines strong electrical engineering fundamentals with hands-on product development experience and a deep understanding of manufacturing processes. This role will play a critical part in New Product Introduction (NPI), design reviews, technical troubleshooting, supplier collaboration, and continuous product improvement efforts across electromechanical medical device products.This is a highly collaborative position requiring close interaction with customers, manufacturing teams, quality organizations, and supply chain partners across multiple global locations, including China and future manufacturing operations in Vietnam.Day-to-Day Responsibilities- Serve as the primary electrical engineering point of contact for customers and manufacturing partners- Support the design, development, and manufacturing of electromechanical medical device products- Review and interpret electrical schematics, technical drawings, specifications, and customer requirements- Lead technical discussions related to electrical systems, component selection, manufacturability, and product performance- Support New Product Introduction (NPI) efforts, including product launches and manufacturing transfers- Collaborate with manufacturing, quality, and sourcing teams to resolve technical issues and improve product reliability- Conduct root cause investigations and implement corrective actions for product and production issues- Drive Design for Manufacturing (DFM) initiatives to improve quality, cost, and scalability- Partner with suppliers and offshore engineering teams to ensure adherence to customer specifications and quality standards- Support costing exercises, sourcing decisions, and feasibility assessments for new products- Communicate project status, technical risks, and engineering recommendations to internal and external stakeholders- Travel internationally, as needed, to support manufacturing operations, supplier development, and product launchesWe 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 Electrical Engineer to join a leading medical device manufacturing company. This role is responsible for leading electrical engineering activities that support both new... More and sustaining medical devices, including managing IEC 60601-1 safety and EMC compliance testing, serving as the primary liaison with external test laboratories, troubleshooting failures, and documenting test plans and reports. The engineer evaluates design changes from component-level updates through complete systems, performs BOM replacement assessments, conducts electrical testing of PCBAs and finished products, analyzes failures, and ensures compatibility between medical devices and system components. Working closely with manufacturing, quality, regulatory, sourcing, and cross-functional engineering teams, this individual supports product development, sustaining engineering, and regulatory submissions while ensuring compliance with applicable standards and internal quality system 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 searching for an R&D Engineer III for a leading medical device client located in Maple Grove, MN. This individual will support the development of innovative medical device... More technologies, products, materials, processes, and equipment within a fast-paced R&D environment. The R&D Engineer III will independently lead significant portions of complex engineering projects while collaborating with cross-functional teams to drive product improvements and design changes. This role will be responsible for executing engineering investigations, analyzing testing and research data, initiating and managing design changes, supporting CAPA/NCEP/SCAR activities, and ensuring engineering documentation is completed in accordance with company quality standards. The ideal candidate will have experience working within the medical device industry and possess a strong understanding of engineering prints, product development processes, and change management.On a day-to-day basis, this engineer will design and coordinate engineering tests, evaluate product performance, analyze complex data sets, and communicate findings through technical reports and presentations. They will partner closely with quality, manufacturing, process development, regulatory, clinical, and marketing teams to ensure successful project execution. This role will also interact with physicians and Cath Lab personnel to gather feedback on product performance and translate customer needs into product requirements and design specifications. Success in this position requires strong technical problem-solving abilities, hands-on engineering experience, and the ability to manage multiple priorities with minimal supervision while maintaining compliance with all quality system 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 looking for Senior Technical Writer to support a leading medical device manufacturer to partner closely with cross-functional teams to create instructions for use (IFUs) in XML... More based content management system and supporting documentation for implantable medical devices. This person will play a key role in ensuring documentation meets global regulatory requirements while supporting product development, marketing, sales and compliance objectives.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