Director, Systems Engineering
New
Remote - USFull-TimeDirector
Salary182,000 - 237,000 USD per year
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Job Details
- Experience
- 15+ years in regulated medical device development; 8+ years of people leadership
- Required Skills
- Risk Management
Requirements
- BS in Systems Engineering, Electrical Engineering, Biomedical Engineering, or related field (MS/MBA a plus).
- 15+ years in regulated medical device development (Class II/III).
- 8+ years of people leadership managing multidisciplinary engineering teams.
- Expertise in systems engineering: requirements management, architecture definition, and traceability.
- Experience developing medical device platforms including hardware, firmware, and tools.
- Knowledge of FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601.
- Proven leadership in system-level risk management (hazard analysis, FMEA) and design change execution.
- Experience with verification strategy, test planning, and robust evidence for regulatory releases.
- Strong executive communication and cross-functional leadership skills.
- Experience supporting global regulatory submissions (FDA, EU MDR).
Responsibilities
- Lead, develop, and mentor multidisciplinary Systems Engineering and Test teams supporting product development of cardiac diagnostic technologies from concept through commercial launch.
- Own functional strategy, execution priorities, resource planning, and operating model for Systems Engineering.
- Drive adoption of improved engineering processes, tools, and best practices while maintaining compliance standards.
- Lead system-level requirements management, ensuring user needs are translated into clear, testable, and traceable requirements.
- Communicate project status, risks, budget, and resource needs to executive leadership.
- Partner cross-functionally with RA/QA, Product Management, and R&D to ensure design inputs and outputs meet regulatory and patient needs.
- Support regulatory inquiries, audits, and inspections.
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