Job Search Results for medical device regulations

The QA Complaints Investigator is responsible for supporting complaint handling and investigation activities for the Concord manufacturing site. Key responsibilities include:?Conduct thorough... More complaint investigations related to manufacturing and packaging, including prefilled devices, drug-device combination products, and drug products.?Initiate and support technical investigations, including trend workflows (TW), root cause investigations (RCIs), and associated tasks, as applicable.?Perform routine and ad hoc trend analysis to evaluate product and process performance, including quarterly reviews.?Meet established complaint team productivity and cycle time metrics.?Partner cross functionally with SMEs across Quality, Manufacturing, Engineering, and Technical Services to support investigations.?Maintain ownership and accountability for all assigned investigations and associated system tasks.?Monitor, triage, and document incoming complaints on a daily basis.?Compile and report complaint metrics, including monthly, quarterly, and ad hoc analysis.?Develop a strong understanding of device, combination product, and parenteral packaging processes to effectively support investigations.?Collaborate with internal and external stakeholders to provide timely updates and ensure high quality customer service.?Support continuous improvement initiatives and productivity efforts within the complaints function.?Prepare and present complaint data and insights to site leadership, flow teams, and process teams.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 Product Development Engineer will support medical device development programs with a primary focus on design verification testing and downstream validation activities. This role contributes... More across multiple project phases, including test method development, protocol execution, and report generation, while partnering cross-functionally with Quality, Regulatory, Manufacturing, and external suppliers. Engineers will work on defined components while maintaining strong system-level awareness within highly regulated environments.Compensation: $50/hr to $65/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

Job Title: Biomedical Engineer Level 3Location: Philadelphia, PA 19104Department: Clinical EngineeringJob Type: Full-Time M-F 8-4:30 1 Year Contract Summary:We are seeking a highly skilled and... More experienced Biomedical Engineer Level 3 to join our Clinical Engineering team. This role is responsible for leading complex biomedical engineering projects, ensuring the safe and effective use of medical equipment, and supporting innovation in patient care technologies across the health system.Key Responsibilities:- Lead advanced troubleshooting, repair, and calibration of sophisticated medical devices and systems.- Serve as a technical expert and mentor for junior biomedical engineers and technicians.- Collaborate with clinical departments to assess equipment needs and recommend solutions.- Manage equipment lifecycle including acquisition, installation, preventive maintenance, and decommissioning.- Ensure compliance with regulatory standards (e.g., FDA, Joint Commission, NFPA).- Support capital planning and budgeting for medical equipment.- Participate in risk assessments and incident investigations related to medical devices.- Interface with vendors and service providers to coordinate support and upgrades.- Contribute to research and development initiatives and technology evaluations.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 Sr. Validation Engineer for a top medical device client. This individual will play a critical role in supporting separation activities by ensuring all software-driven... More manufacturing systems meet regulatory and quality standards. The engineer will focus heavily on validating HMI programs, executing protocols, and partnering cross-functionally to ensure a smooth transition. This is a high-impact role ideal for someone who thrives in fast-paced, regulated environments and has experience navigating complex validation projects.Compensation: $80/hr to $100/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

We are seeking a Senior iOS Developer to join a globally distributed mobile engineering team supporting a medical device mobile application. This role is heavily hands-on while also providing... More technical leadership and mentorship to junior engineers across multiple locations.You?ll work on a native iOS application used to control Bluetooth-enabled hearing aids and provide health-related features such as fall detection, activity tracking, and device configuration.Key ResponsibilitiesDesign and develop native iOS applications using SwiftBreak down complex product requirements into clear, executable technical solutionsGuide and mentor junior and mid-level engineers (approximately 30?40% of the role)Collaborate daily with offshore development teams (India, China, Israel)Participate in design discussions, code reviews, and architectural decisionsWork closely with product, verification, and hardware teamsBuild stable, regulated software within a medical device environment (quality, documentation, review-heavy process)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.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 and specialty gas supplier is seeking an IT Support Specialist to join their team in Lawrenceville, GA. This person will provide hands-on technical support during a period of... More increased onboarding and device deployment.This role supports an employee on leave and a large rollout of computers and mobile devices for new hires. The ideal candidate will have hands-on experience with Active Directory, setting up printers, and performing data transfers such as migrating user files and settings from one device to another. A strong plus is comfort with Apple devices, including iPads and iPhones, especially in setting up work emails on mobile devices. Excellent customer service skills, a positive attitude, and a willingness to learn and listen are essential. This role is perfect for someone who enjoys solving problems, supporting end users, and growing their technical skills in a collaborative 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

A large medical and specialty gas supplier is seeking an IT Support Specialist to join their team in Lawrenceville, GA. This person will provide hands-on technical support during a period of... More increased onboarding and device deployment.This role supports an employee on leave and a large rollout of computers and mobile devices for new hires. The ideal candidate will have hands-on experience with Active Directory, setting up printers, and performing data transfers such as migrating user files and settings from one device to another. A strong plus is comfort with Apple devices, including iPads and iPhones, especially in setting up work emails on mobile devices. Excellent customer service skills, a positive attitude, and a willingness to learn and listen are essential. This role is perfect for someone who enjoys solving problems, supporting end users, and growing their technical skills in a collaborative 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

The Senior Manager, Regulatory Affairs will own and drive all regulatory activities across the product lifecycle for our regulated products portfolio. The role will ensure compliance with U.S.... More regulations (e.g., 21 CFR Part 820) and global standards (e.g., ISO 13485, ISO 14971), support future expansion into international markets and higher classification devices, and serve as a strategic regulatory partner to senior leadership. This role is critical to the company?s next phase of growth and will lead a significant overhaul of regulatory processes, ensuring the organization is prepared for increased regulatory scrutiny, expanded product claims, and future global market access.This individual will operate in a lean, evolving environment, where ambiguity is common and ethical decision-making is paramount. The successful candidate will be hands-on, pragmatic, and capable of building structure where little currently exists, while serving as a strategic regulatory partner to senior leadership.This role is an individual contributor with the opportunity to grow into people leadership. Top Priorities ?Regulatory remediation and reclassification efforts across a large portfolio (~2,000 products), supporting the transition from Class I to Class II?End-to-end regulatory impact assessments, including labeling, claims, and submission strategy?Health hazard evaluations ?Risk analysis ?MDR (medical device reporting)?Establishing foundational regulatory processes to support scale, audits, and future submissions$140,000 to $150,000. - Exact compensation may vary based on several factors, including 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 Marketing Analyst to join one of our clients? marketing technology teams focused on CRM and marketing automation. This role will support the build, configuration, and... More optimization of automated email and SMS journeys that guide prospective patients through a defined care pathway, from initial consultation through implant scheduling and completion. The Marketing Analyst will work closely with marketing, sales, IT, and product partners to implement hands-on CRM solutions, launch and manage drip campaigns, and analyze engagement and pipeline outcomes. The ideal candidate has strong CRM implementation experience, enjoys being technically involved in execution (not just strategy), and is comfortable working in a regulated healthcare or medical device environment where accuracy, thoughtful problem-solving, and data integrity are criticalResponsibilities:- Lead and manage marketing technology initiatives including workflow design, segmentation, and multi-channel campaign execution- Partner with marketing teams to design, launch, and analyze campaigns using Dynamics 365 Marketing or similar platforms- Analyze and optimize CRM functionality to support lead generation, sales enablement, and post-market engagement- Translate business needs into CRM workflows, automated journeys, and lead scoring models- Monitor and improve nurture journeys based on segmentation and engagement performance- Conduct system audits and maintain data accuracy in compliance with HIPAA, GDPR, and medical device regulations- Collaborate with IT and technical teams on system integrations- Support training and user adoption for new marketing automation and CRM featuresWe 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/.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