Director, Systems Engineering
New
Flexible remote work arrangement within the United StatesFull-TimeDirector
Salary182,000 - 237,000 USD per year
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Job Details
- Experience
- 15+ years of experience in regulated medical device development, including Class II/III environments and connected systems; 8+ years of leadership experience
- Required Skills
- Risk Management
Requirements
- Bachelor’s degree in Systems, Electrical, Biomedical Engineering, or related field
- 15+ years of experience in regulated medical device development
- 8+ years of leadership experience managing multidisciplinary engineering teams
- Experience with Class II/III environments and connected systems
- Expertise in requirements management, architecture design, interface control, and verification planning
- Strong understanding of risk management tools such as hazard analysis and FMEA
- Familiarity with global regulatory frameworks including FDA, EU MDR, and international standards
Responsibilities
- Define and execute the Systems Engineering strategy, operating model, and resource planning
- Lead system-level requirements management and traceability
- Oversee architecture definition, interface control, and risk management
- Guide cross-functional collaboration with RA/QA, Product, Clinical, and R&D
- Drive systems engineering best practices including design controls and configuration management
- Lead regulatory readiness and support audits, inspections, and submissions
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