Job Description

Compensation:

$108k-$115k per year annual salary. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role may include healthcare

insurance offerings and paid leave as provided by applicable law.

Job Description:

In this role, responsibilities include maintaining and supporting medical electrical equipment electrophysiology recording systems and RF therapy capital equipment. Include 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. Reviews authors change notices quality records potential audits and participation in lab experiments with R&D and the ability to present technical subjects (design perspectives) to directors and VP's.

Must haves:

• Bachelor's degree in electrical engineering, mechanical engineering, computer engineering, biomedical engineering, physics, or aerospace
• 3+ years of experience with design assurance/ quality and sustaining or R&D engineering
• Medical device CAPA capital equipment experience
• Interested in someone that works with it that the company makes that’s bought by a customer

Nice to have skills and experiences:

• 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

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