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
- Required Skills
- Cross-functional Team LeadershipRisk Management
Requirements
- BS in Systems Engineering, Electrical Engineering, Biomedical Engineering or related engineering degree; MS/MBA a plus.
- 15+ years in regulated medical device development (Class II/III) with deep experience in Systems Engineering.
- 8+ years of people leadership managing multidisciplinary engineering teams.
- Expertise in systems engineering best practices including requirements, architecture, and configuration management.
- Experience developing medical device platforms including hardware, firmware, and tools/fixtures.
- Working knowledge of FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601.
- Proven leadership of system-level risk management and design change execution.
- Proven ownership of verification strategy and execution.
- Strong executive communication and cross-functional leadership skills.
- Experience supporting global regulatory submissions including FDA and EU MDR.
Responsibilities
- Lead, develop, and mentor multidisciplinary Systems Engineering and Test teams supporting product development of cardiac diagnostic technologies.
- Own functional strategy, execution priorities, resource planning, and operating model for Systems Engineering.
- Serve as a change agent driving adoption of improved engineering processes, tools, and best practices.
- Lead system-level requirements management, ensuring user needs are translated into clear, testable, traceable product requirements.
- Communicate project status, risks, budget, and resource needs to executive leadership.
- Provide leadership support for external vendor partnerships, engineering evaluations, and verification testing.
- Partner cross-functionally with RA/QA, Product Management, and R&D to ensure design inputs and outputs meet needs.
- Sponsor a Systems Engineering community of practice.
- Provide oversight and targeted participation in QMS improvement initiatives.
- Support regulatory inquiries, audits, and technical discussions.
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