Job Description
In this role, responsibilities include maintaining and supporting medical electrical equipment for products on the market. including managing change notices, monitoring post-market product performance, implementing product modifications, and ensuring nonconformance and CAPA compliance. Actively participate in various forums, standards councils, and cross-functional teams to support coordination across different geographic regions. Responsible for maintaining legacy products, supporting post-market reporting (PMVP, PMVR, PMSR), and managing Quality System deviations. Led audit support, NCEP/CAPA processes, and quality tracking across complex, multi-site environments. Applied systematic problem-solving, mentored teams, and drove process improvements aligned with VIP and Continuous Improvement goals. Knowledgeable in End-of-Life processes and regulatory standards.
Salary: $108k-$115k
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/.
Required Skills & Experience
-Bachelor's degree in electrical engineering, mechanical engineering, computer engineering, biomedical engineering, physics, chemical or aerospace
-3+ years of experience with design assurance/ quality and sustaining or R&D engineering
-Medical device CAPA equipment experience
Nice to Have Skills & Experience
- IEC 60601 experience
-Experience with medical standards for compliance including ISO 13485, ISO 14971 and FDA quality system regulations, specifically focused on design controls
- Experience in post market quality CAPA's (corrective and preventative action)
-Experience in design engineering, process development and continuation engineering
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.