Job Search Results for medical device regulations

Insight Global is seeking a Billing Specialist for a rapidly growing healthcare technology client in the medical device space. This individual will play a vital role in ensuring accurate and timely... More billing operations across Medicare, Medicaid, and commercial payers. The ideal candidate is detail-oriented, proactive, and experienced in navigating complex insurance processes, including claims submission, payment posting, and denial resolution. This role offers the opportunity to contribute to a mission-driven organization while helping optimize revenue cycle operations and improve overall billing efficiency in a fast-paced, 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 device client of ours is looking for an Analytical Chemist to join their NMR spectroscopy team. This individual will apply Nuclear Magnetic Resonance Spectroscopy techniques to... More support research and development, identify trace unknown impurities in complex polymer matrices, degradation products of polymer systems, small molecule/polymer interaction products, conduct extractable/leachable studies, maintain Nuclear Magnetic Resonance Spectrometer, Interpret test results and author scientific reports, and collaborate with inter-disciplinary colleagues such as toxicologists, engineers, polymer chemists, etc.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 Jr. Product Manager in the Cincinnati, OH area for a long term opportunity. This Jr. PM will be joining a leader in the medical device industry to support product/material... More discontinuation initiatives for multiple suppliers, international and external manufacturing sites as well as cross functional leaders across the engineering lifecycle. The day-to-day responsibilities will include program coordination and planning within Smartsheet for driving milestones, risks and decision points while tracking project timelines and burn down for the suppliers. They will also support supplier site coordination, discontinuation communication and coordinating sourcing, planning, quality, regulatory and operations check points while the company successfully moves towards other suppliers. Prior experience in a regulated environment would be ideal as well as strong organization and communication skills. This role will be on site three days a week and remote the other two.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 fortune 500 company is looking for a candidate to be a part of a growing team in support of the development of a cutting edge medical device. This individual will collaborate with cross-functional... More teams to define, design, and deploy new features and applications. They will also ensure high-quality code through best practices in unit testing, code review, and continuous integration. They will also collaborate with cross-functional teams including DevOps, QA, and product management to drive continuous delivery pipelines and automation. In addition they will develop and document software in compliance with regulated industry standards, specifically in the medical device space, adhering to frameworks like IEC 62304. This role is hybrid, 3 days onsite, Wednesday 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

A client in the medical device space is seeking a Sr. Software Quality Assurance Engineer to join their organization for a defined two-year term to backfill a team member assigned to internal... More projects. The ideal resource will be well versed in Quality SW principles within the medical device industry and have deep expertise in risk assessment, testing, and design validation. This resource should be detail oriented with strong documentation and able to identify risks and process improvements on their own to share with cross functional teams including R+D, Marketing, Regulatory, etc. This resource?s time will be split up into 50% design validation activities, 30% SDLC work, and 20% risk management through testing. This role will be hybrid, onsite 3 days per week in Valencia, CA.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 Summary:Driven by our purpose to enable healthier lives everywhere, every day, we are seeking a talented and experienced Electrical Engineer to join a growing R&D department in our Surgical... More Division to contribute to new product development of both Capital and Disposable products. Our team is customer focused, working to enhance the user's experience through improving our system's performance, compliance and reliability through state of art hardware design and selection, robust testing, and analysis. In this role you will have the opportunity of working cross functionally with groups such as Quality, Regulatory, and Manufacturing as part of the development cycle.The Lead Electrical Engineer, NPD, delivers value by driving the design and selection of HW that meets the needs of both the customer and the business. This role will be responsible for prototyping, analyzing, and documenting design concepts throughout the NPD cycle. As such, this role requires robust familiarity with design and troubleshooting tools. This role will also support senior level EEs in the design and development of PCBs for control of various subsystems within our capital portfolio. As such, this role will be a champion for state-of-art design practices, including robust design reviews. The Lead Electrical Engineer has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Determines methods and procedures on new assignments and coordinate activities of other personnel as a Team Lead.Essential Duties and Responsibilities: ?Functions as a technical lead for the electrical engineering discipline and can effectively coordinate and contribute to simultaneous programs or projects of varying sizes. ?Participates in product and cross functional product and project teams. ?Represents Electrical Engineering and department culture through example, leadership and excellent communication skills. ?Owns architectural specifications of electrical and electronic systems and subsystems for medical device development. ?Performs and guides lower-level engineers in electrical design, design reviews, and design for manufacturability.?Specifies, evaluates, and selects electronic and electro-mechanical components to meet product specifications. ?Leads design responsibilities such as design, analysis or trouble shooting of printed circuit assemblies, cable and harnessing design, power conversion circuits, analog conversion, filtering circuits, power distribution, and developing CAD schematics for electrical assembly or PCB design. ?Develops, builds, and maintains electrical test fixtures, test control apparatus and equipment to support the development process.?Develops methods of verification of electrical components, PCBs, and subsystems.?Drives a culture of continuous learning and improvement. Champions opportunities to introduce new technologies, systems, methods, and controls and deliver design, quality, cost or time-to-market improvements. ?Works with contract manufacturers and vendors/suppliers to ensure device design and parts meet functionality and medical device quality and regulatory standards. ?Establishes collaborative relationships with all stakeholders within the division and create links with experts within the Hologic network and outside.?Stays current with emerging technologies and processes to support ongoing innovation. ?Trains and mentors lower-level engineers to further develop and impact the organization. Compensation: $150,000 to $170,000. 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 an experienced, highly skilled Quality Engineer to support an established medical supply client out of Chicago, IL. The Quality Engineer will provide cross-divisional... More support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR?s, product specifications, design control files, and CE technical files.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

? 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

Insight Global's customer is seeking a mid-level Test Engineer to join a growing team responsible for testing software that controls robotic medical devices in Durham, NC. This role will require... More coming onsite 2-3 days each week.This role was created to support new projects and reduce current testing bottlenecks as development efforts continue to scale. You?ll work closely with software engineers and QA leadership to ensure high-quality, reliable software in a highly regulated, patient-impacting environment. The work is hands-on and detail-oriented, combining manual testing, system setup, and physical device interaction, with a gradual transition toward test automation.Responsibilities:? Develop detailed test plans, scenarios, and scripts.? Execute, analyze, and document test results.? Troubleshoot issues and collaborate with developers on corrective actions.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