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
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-Bachelor's degree in electrical engineering/mechanical engineering or biomedical
-5+ years of experience with design assurance, sustaining or R&D engineering
-Experience with standards specifically IEC 60601
- 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.