Job Search Results for medical device regulations

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. This role partners closely with Operations and Product Development teams to ensure compliance with current Good Manufacturing Practices (cGMP) and 21 CFR Part 4 requirements for drug-device combination products manufactured in the Urology business. The individual will lead quality and continuous improvement initiatives, serve as the technical quality lead during audits, analyze quality data and manufacturing metrics to identify trends and drive corrective actions, and collaborate with cross-functional teams to reduce defects, nonconformances, and customer complaints. Responsibilities also include developing quality plans, specifications, risk assessments, FMEAs, process monitoring systems, training materials, and quality tools; supporting product containment and release activities; evaluating the effectiveness of quality systems and manufacturing operations; and conducting internal audits to support ongoing compliance and continuous improvement within the client Quality System.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

We are seeking a self-motivated mid-senior Embedded Software Developer to join a large medical device client in the Pittsburgh area. This person should have strong C/C++ firmware development... More background within a highly regulated environment. The ideal candidate will have experience in a hands-on functional and technical aspects of the SDLC, including design and development, as well as testing and de-bugging.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 an employee for a long-term contract opportunity . They will be supporting the Promotional Integrity team at one of our largest Medical Device companies. On a weekly... More basis, this individual will be partnering with the team to submit assets to copy approval through their compliance workflow tool for approval. They will manage the copy approval process from start to finish including submitting the original asset with the appropriate linked references and links, attend meetings with Copy approval colleagues to understand requested changes, communicate 1:1 with copy review team members as needed to talk through specific changes outside of the copy approval meetings, work to relay requests to MPEs, and resubmit for approval. The individual will also need to ensure all assets have the most updated branding. In addition, this role requires the individual to manage and update assets on both internal and external platforms. It is important that this employee possess excellent and professional communication (both written & verbal), project management, high attention to detail and organizational skills. To be successful, they must be highly detail-oriented, able to thrive in tight deadline situations and maintain collaborative working relationships. Navigating relationships with internal groups that have different agendas but are integral to the success of the job or team is critical to success. Ability to adapt to the Global Education team?s set processes as well as be proactive in identifying and leading projects that will provide value or efficiencies to the Professional Education team. The work schedule is primarily business hours on Eastern time, with some flexibility required based on high priority needs. Occasional evenings and occasionally weekends may be required.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 Project Manager III to support a leading medical device client in Carlsbad, California. This individual will support the Intravascular Lithotripsy (IVL) Catheter Portfolio... More within the Coronary and Peripheral Artery Disease business. Reporting to the Associate Director of the PMO, this person will manage sustaining engineering projects and product lifecycle activities from initial launch through end-of-life.The ideal candidate will have a strong background managing cross-functional medical device projects, driving process improvements, design changes, design transfers, and business continuity initiatives. This role requires close collaboration with engineering, quality, manufacturing, regulatory, and other functional teams across global sites.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 seeking a Quality Engineer / Senior Quality Engineer to support manufacturing quality, supplier quality, and quality system activities within a regulated medical device environment. This... More individual will play a key role in ensuring products meet established quality standards throughout the manufacturing process while partnering closely with Manufacturing Engineering, Operations, and Suppliers.The Quality Engineer will be responsible for developing inspection methods, leading nonconformance investigations, supporting CAPA activities, managing supplier quality initiatives, and participating in validation activities. This role requires a hands-on engineer who can work cross-functionally to identify root causes, implement corrective actions, and drive continuous improvement efforts within the Quality Management System (QMS).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

Insight Global is seeking a Labeling Project Manager for a leading medical device client within the orthopaedics space. This individual will play a critical role in implementing a new labeling system... More while driving process harmonization and standardization across global teams. The role combines hands-on project management with cross-functional collaboration across quality, regulatory, IT, and supply chain to ensure compliance and successful system adoption. The ideal candidate brings strong experience in regulated environments, excels at managing complex stakeholder landscapes, and is passionate about improving labeling processes to support high-quality patient outcomes.Compensation: $58/hr to $63/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

Our client is seeking an MQSA Engineer to join the Quality Systems team. This role ensures compliance with microbiological quality and sterility assurance standards across manufacturing and product... More development processes. The ideal candidate will have expertise in sterility assurance, microbiology, and regulatory compliance within a medical device environment.Key Responsibilities-Develop, implement, and maintain sterility assurance programs for medical devices in compliance with FDA QSR, ISO 13485, and ISO 11135/11137 standards.-Provide technical leadership for cleanroom validation, bioburden testing, and environmental monitoring programs.-Support sterilization process development and validation (e.g., ethylene oxide, gamma, steam, or gaseous sterilization methods).-Conduct risk assessments related to microbiological contamination and sterility assurance.-Collaborate with R&D, Manufacturing, and Quality teams to ensure sterility requirements are integrated into product design and production processes.-Author and maintain SOPs, protocols, and reports for sterility assurance activities.-Lead investigations for sterility-related non-conformances and implement corrective/preventive actions (CAPA).-Support internal and external audits, including regulatory inspections.-Provide training and guidance on microbiological quality and sterility assurance best practices.Compensation: $40/hr to $48/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

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

Our client, an innovative medical device company focused on diabetes care, is seeking an Embedded Software Engineer to support the development and ongoing enhancement of embedded software for... More commercialized medical device products.This engineer will contribute across two established embedded platforms, helping drive new development efforts while also investigating customer-reported issues, analyzing system logs, supporting software testing and verification activities, and maintaining documentation required within a regulated development environment.The ideal candidate has a strong foundation in embedded software development, hands-on RTOS experience, and enjoys solving complex technical challenges while collaborating with cross-functional teams to deliver reliable, high-quality products.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