Job Search Results for medical device regulations

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

A client in the medical device industry is seeking a Sr. Quality Engineer to join their team in support of ongoing remediation projects in their Neuromodulation suite of products. The ideal candidate... More will have a strong Quality Engineering background with demonstrated excellence in Risk Management/documentation and Design Controls for both new product and sustaining development. An understanding of the Neuromodulation space, hands on Electrical/Mechanical Engineering experience, as well as any certifications in Quality Engineering are a plus. This opportunity will be a 12-month contract with possible extensions and hybrid, with expectations to be onsite in Heredia CR at the client location Tues-Wed-Thurs each week.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 Unified Communications Engineer to design, deploy, and support enterprise communication and collaboration solutions across a campus-based and remote healthcare... More environment. This role is responsible for maintaining highly available voice, video, messaging, conferencing, and mobility solutions that support clinical and business operations.This is a hands-on engineering role, not project management. The engineer will lead Tier-3 troubleshooting, support incident and disaster response communications, and partner closely with clinical teams, IT leadership, and vendors to improve communication reliability and user experience. The role also contributes to enterprise mobility strategy, conference room solutions, and ongoing optimization of unified communications platforms.This position is ideal for a senior-level UC engineer with healthcare experience who enjoys owning complex systems, mentoring others, and supporting mission-critical communications in a hospital 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

Insight Global is seeking a Medical Device Design Engineer Supervisor to support a leading medical device manufacturer. This person will oversee the design and development of reusable surgical... More instruments and mechanical components, combining hands on engineering with team leadership. The role guides projects from early concept through testing, documentation, and release to manufacturing, while ensuring compliance with FDA/ISO quality requirements and driving continuous improvement across the product lifecycle.Annual Salary Range: $100,000 (based on various factors including experience and educational background)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

Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms). Develop V&V test plans, test procedures, and test reports. Review requirements and scrutinize... More for testability. Quickly learn to use automated test tools and specialty test equipment; develop and validate automated test scripts. Execute test procedures both personally and using test technicians. Log defects and issues found during V&V activities and track to closure. Perform regression analysis and determine testing associated with design changes. Provide weekly project status reports. Prioritize project tasks to complete on schedule while maintaining quality of work. Work in a team environment; peer review work. Work on multiple, concurrent projects. You are a part of: Our group works closely with the development team throughout the product development process. We play an active role early on in ensuring requirements are complete, unambiguous, and testable, collaborate to develop detailed test plans, and assist with development testing prior to the verification and validation phase. While having our own responsibilities within the group, we look to each other?s strengths for support in doing our jobs.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 Lebanon, TN area is a leading innovator in the medical device industry, dedicated to improving patient outcomes through cutting-edge technology and rigorous research. Their R&D team... More is seeking a Senior Embedded Software Engineer to architect and deliver reliable, safety critical firmware for connected motor driven medical devices. In this on site Lebanon, TN role, you will design and implement C/C++ firmware on RTOS based microcontrollers, develop secure connectivity (BLE/Wi Fi) and high reliability communications (CAN, SPI/I?C), and lead motor control integrations that balance performance, responsiveness, and patient safety. You?ll collaborate cross functionally with Product Management, Mechanical, Electrical, Quality/Regulatory, and Manufacturing to translate clear requirements into verifiable designs, ensure end to end traceability, and support builds, V&V, submissions, and transfer to production. You will apply IEC 62304 practices and work within ISO 13485 and ISO 14971 to document architecture, risk controls, and evidence for EU MDR & FDA, while continuously improving code quality, tooling, and CI workflows. Successful candidates bring deep embedded expertise, rigorous test and debug skills, and the judgment to ship iteratively while maintaining compliance and reliability for users worldwideEssential Duties and Responsibilities:Responsibilities may include:?Design & implement embedded firmware in C/C++ for microcontroller-based systems leveraging RTOS for deterministic, safety critical operation.?Develop connectivity features (Bluetooth/BLE, Wi Fi) and robust communications (CAN bus, SPI/I?C) for multi-board, multi-sensor systems.?Own motor control firmware: integrate motor drivers/control circuits, implement control loops, and optimize performance, responsiveness, and safety.?Contribute to safety & compliance: apply IEC 62304 software lifecycle practices, support IEC 60601 electrical safety/EMC considerations, ISO 13485 QMS, and ISO 14971 risk management (hazard analysis, risk controls, traceability).?Document and trace requirements, architecture, design, risk controls, verification, and defects in Agile/Jira with end-to-end traceability.?Test rigorously: create unit and integration tests, bring up hardware, perform fault injection, and support verification/validation activities.?Tooling & automation: build developer tooling and scripts in Python; contribute to CI workflows; instrument firmware for diagnostics and telemetry.?Cross-functional collaboration: partner with Electrical, Systems, Quality/Regulatory, Manufacturing, and Field Service to support builds, audits, transfers to production, and post market improvements.?Regulatory support: prepare technical documentation and evidence for UL, FCC, and FDA submissions in collaboration with Regulatory Affairs and Quality.?Continuous improvement: drive code reviews, design reviews, and process improvements to enhance reliability, security, and developer productivity.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 Operations Manager (1st Shift) to support a medical device manufacturing operation in Norwood, MA. This is a full-time, onsite leadership role responsible for overseeing... More first-shift operations across two manufacturing buildings and leading a high-performing operations team.Day-to-Day Responsibilities-Lead and motivate manufacturing teams across two facilities, fostering a culture of accountability, collaboration, and continuous improvement.-Manage daily production output, quality performance, shop floor controls, and task assignments.-Partner with planning, production supervisors, and engineering to manage day-to-day production activities.-Implement and maintain manufacturing process controls and quality standards to ensure compliance with customer, GMP, and ISO 13485 requirements.-Drive strategies to scale manufacturing operations in support of future growth.-Conduct resource planning and proactively identify staffing, equipment, and capability gaps.-Coach, mentor, and develop supervisors, leads, and production associates, including onboarding and performance development.-Establish and lead Lean manufacturing initiatives, including daily standups, Gemba walks, and continuous improvement projects.-Identify and implement process improvements to increase efficiency and reduce costs.-Collaborate with senior leadership and HR on hiring needs, training requirements, and workforce planning.-Ensure compliance with Quality, EHS, and OSHA requirements, policies, and procedures.-Establish departmental goals, track KPIs, manage budgets, and oversee departmental expenses.-Support performance management activities, including feedback, disciplinary actions, promotions, and performance reviews.-Perform other related duties as assigned.Compensation:$140,000 - $150,000 per year (annual salary)Exact compensation may vary based on skills, experience, and education.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

Insight Global is seeking an eager and motivated professional to help join a medical device company located in Minnetonka, MN. This resource will be joining a highly collaborative team in one of the... More largest Medical Device companies headquartered in Marlborough, MA. This resource will be working with Sr. Lab Engineers and a Researcher to develop testing methods and executing those methods to complete the vision of the Researcher. This resource will need to be comfortable with being independent, drive tests/studies, and not be afraid to fail.Daily work will be in an R&D environment working on single use as well as capital medical equipment. There will be pockets of sustainability functions, but primarily in an R&D role. This position will be required to be 100% onsite 1st shift. 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 Warehouse Material Picker I to support inventory control and distribution operations at Boston Scientific?s Rochester, MN facility. This role will focus on material... More handling, kitting, shipping, and returned goods processing in a regulated medical device environment. The position is fully on-site and requires close collaboration with Quality, Operations, and Supply Chain teams to ensure accurate inventory tracking and timely product fulfillment. Ideal candidates will have prior warehouse or inventory experience, strong attention to detail, and the ability to operate effectively in a fast-paced setting.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