Medical Device Engineering Lead (VP Level)
Skills
- Deep expertise in regulated medical device development (Class II or III).
- Experience with FDA QMSR 21 CFR 820, ISO 13485, IEC 60601, ISO 14971, and IEC 62304.
- Strong leadership of cross-functional engineering teams.
- Hands-on hardware and systems engineering skills.
- Excellent communication bridging technical and executive levels.
- Knowledge of design control, risk management, and verification/validation practices.
Responsibilities
- Lead cross-functional engineering teams across mechanical, electrical, firmware, and systems disciplines.
- Translate strategic vision into executable engineering plans that meet product, regulatory, and business goals.
- Oversee hardware/software integration in compliance with FDA Class II medical device standards.
- Ensure design control and documentation aligned with ISO 13485 and FDA QMSR.
- Collaborate with Regulatory, Clinical, Quality teams to support FDA filings including Pre-Sub and 510(k).
- Drive root cause analysis and resolution for hardware issues with Quality and Operations.
- Manage, mentor, and develop multidisciplinary engineering teams.
- Partner with executive leadership and cross-functional groups to align engineering with business milestones.
- Establish scalable engineering processes for requirements management, risk mitigation, and issue tracking.
- Monitor engineering budgets, resources, and schedules for on-time delivery.
Education
- Bachelor's degree in Electrical, Mechanical, Biomedical Engineering, or related field required.
- Master’s or advanced technical degree preferred.
Benefits
- Flexible part-time work model with hybrid onsite requirements.
- Opportunity to lead transformative neurodegenerative therapeutics development.
- Engagement with cutting-edge medical device innovation and regulatory pathways.
- Collaborative, mission-driven startup culture.
Average salary estimate
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