Director, Systems Engineering
New
I
iRhythmMedical Devices
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
- Cross-functional Team LeadershipRisk Management
Requirements
- BS in Systems Engineering, Electrical Engineering, Biomedical Engineering or related field; MS/MBA a plus.
- 15+ years of experience in regulated medical device development (Class II/III), including NPI and sustaining/lifecycle management.
- 8+ years of people leadership managing multidisciplinary engineering teams.
- Expertise in systems engineering best practices: requirements management, architecture definition, and configuration management.
- Experience developing medical device platforms including hardware, firmware, and integration tools.
- Working 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 (dFMEA/pFMEA/uFMEA) and design change execution.
- Experience with verification strategy, test planning, and robust evidence documentation for regulatory submissions.
- Strong executive communication skills and ability to manage cross-functional vendor/partner governance.
- Experience supporting global regulatory submissions (FDA, EU MDR).
- Availability for up to 25% domestic travel.
Responsibilities
- Lead, develop, and mentor multidisciplinary Systems Engineering and Test teams from concept through commercial launch and lifecycle engineering.
- Own functional strategy, execution priorities, resource planning, and operating model for Systems Engineering.
- Drive adoption of improved engineering processes, tools, and best practices as a change agent.
- 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.
- Provide leadership support for external vendor partnerships and verification testing.
- Partner cross-functionally with RA/QA, Product Management, and R&D to ensure design inputs and outputs meet business and quality needs.
- Sponsor a Systems Engineering community of practice to promote industry standards and training.
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