Job Search Results for medical device regulations

An employer is seeking Senior Equipment Process Engineer to support New Product Development (NPD) and manufacturing scale-up of medical devices in a regulated environment. This role will be long term... More and located in the Blue Ash, OH area. The equipment process engineer will be responsible for the development, qualification, and optimization of custom manufacturing equipment and processes that meet stringent quality, reliability, and regulatory requirements. The ideal candidate brings deep expertise in equipment-centric process development, supplier collaboration, and material-sensitive manufacturing processes, with a strong understanding of FDA and ISO expectations.The core responsibilities will include:-Develop and refine New Product Development (NPD) processes in compliance with FDA, ISO 13485, and internal quality system requirements.-Partner with equipment suppliers to design, build, and qualify new manufacturing equipment and process solutions.-Lead process characterization activities to identify and optimize Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).-Design and execute Design of Experiments (DOE); perform statistical analysis and establish process capability (Cp/Cpk, Pp/Ppk).-Define and implement process control limits, control plans, and monitoring strategies to ensure sustained process performance.-Plan and execute Measurement System Analysis (MSA) and Gage R&R studies to validate measurement methods.-Provide hands-on technical support during equipment development, FAT/SAT, installation, qualification, validation, and production ramp-up.-Qualify and validate PLC-controlled software systems; troubleshoot issues, document changes, and support software fixes.-Collaborate cross-functionally with R&D, Manufacturing, Quality, and Supply Chain to drive compliant, scalable solutions to market.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 seeking a Field Data Engineer for a long term opportunity in the Cincinnati, OH area. This Data Engineer will be tied to multiple NPD projects for a medical device leader and will... More report into the Data Lead over the program. The Field Data Engineer will be required to establish consistency, structure, and scalability across how data is collected, stored, processed, and prepared for deeper analytics. This individual will own the end-to-end data lifecycle for field and test data, driving standardization and enabling reliable downstream analysis. While this is an individual contributor role, it requires strong leadership, initiative, and the ability to independently prioritize work across multiple stakeholders as the stakeholders they will be working with are mechanical and test engineers. Ideally someone with 2+ years in a testing role will be the correct fit for this role. The main responsibilities will include:Data Collection - establish and enforce data collection norms, streamline existing collection processes and participate in data collection. This will be performed utilizing python, git, SQL or other data engineering toolsData Storage: compile, clean, organize, and develop data pipelines and database schemas coming from ~10 collective test stands, including offline equipment. They will also support data transfers via USB and other offline methods, ensuring integrity and traceabilityWe 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

As a Software Test Engineer within our organization, you will play a critical role in verifying software for a groundbreaking robotic surgical platform. This role is highly hands-on and... More domain-driven, requiring deep understanding of complex hardware, embedded systems, and how software interacts with physical devices in a regulated medical environment.This position is ideal for someone with strong manual testing expertise, true medical device or robotics domain knowledge, and experience working at the intersection of hardware, firmware, networking, and software.?Execute manual test cases, test scripts, and formal verification protocols across functional, integration, and system-level testing?Install software on robotic surgical platforms and perform testing on release builds?Perform ad hoc and exploratory testing during development cycles, including defect verification and regression testing?Create, update, and maintain detailed test documentation, scripts, and execution records following formal design verification practices?Work closely with software, firmware, and hardware engineering teams to identify, troubleshoot, and resolve defects?Validate end-to-end workflows involving hardware?software interfacing and device-to-device communication?Support system qualification, instrument qualification, and equivalency testing as required?Use defect tracking and requirements tools to trace coverage and ensure compliance with regulatory expectationsWe 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

? Manage RST RPM/E (release project management/engineering) portfolio CAPAs, ensuring triage, prioritization, timelines, and escalation? Implement and maintain a CAPA tracking workflow? Monitor due... More dates, milestones, and provide weekly/monthly reporting? Forecast resources and funding for CAPA investigations? Identify emerging risks or future CAPAs using metrics, audits, and trend signals? Support project planning, scheduling, risk management, and communication? Participate in SAFe ceremonies, reporting, and continuous improvement efforts? Partner cross-functionally with Quality, RPE Product Engineering, RPE ITI, and Scrum teamsInsight Global is seeking a CAPA Program Manager to support a top medical device client within their RST RPM/E organization. This consultant will manage and mature the CAPA process across multiple value streams, ensuring efficient intake, tracking, reporting, and cross-functional alignment. The ideal candidate brings medical device CAPA experience, strong project management capabilities, exceptional attention to detail, and comfort working within Agile (preferably SAFe) environments. This role is highly visible, working closely with engineering, quality, and leadership teams to drive quality execution and continuous improvement initiatives.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

This role is responsible for executing validation and quality activities required for the introduction and delivery of a new Hinge cast product line, as well as supporting EU MDR validation... More assessment and rationalization. The position operates in a highly regulated medical device manufacturing environment and requires strong expertise in process validation, quality systems, and change control. The successful candidate is a proactive self-starter who collaborates effectively across cross-functional teams to ensure compliance with global regulatory 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 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

An employer is seeking a Program Operations Specialist for a long-term opportunity in the Irvine, CA area. This Specialist will be tasked with driving adoption and customer experience troubleshooting... More of a new digital surgery platform in the medical device industry. The role will support a U.S.-launched solution with plans for global expansion, focusing on improving onboarding, communication, and operational efficiency across stakeholders. This consultant will act as a central point of coordination between sales representatives, surgeons, executive leadership, and technical partners (software development teams). The consultant will simplify complex information into clear, actionable guidance, support onboarding and contracting processes, and proactively address adoption barriers through high-touch communication and process streamlining. Strong Microsoft Suite background (Teams, Excel, PowerPoint and Outlook) will be critical to hitting the ground running and the ideal candidate will be able to go on site to Irvine, CA two days a week. The current workload has 80 open cases and with global adoption planned to help patients visualize potential outcomes in seconds, this app brings clarity to the decision-making process, supports a more confident, personal choice, and has been shown to help patients feel ready to make decisions more quickly.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