Director, Systems Engineering

Responsibilities

• Lead, develop, and mentor multidisciplinary Systems Engineering and Test teams supporting product development of cardiac diagnostic technologies from concept through commercial launch, as well as sustaining and lifecycle engineering activities.
• Own functional strategy, execution priorities, resource planning, and operating model for Systems Engineering, ensuring alignment with business priorities and portfolio roadmaps.
• Serve as an effective change agent by driving adoption of improved engineering processes, tools, and best practices while maintaining team engagement, compliance standards, and organizational momentum.
• Communicate project status, risks, budget, resource needs, and execution priorities to executive leadership in a clear, concise, and actionable manner.
• Partner cross-functionally with RA/QA, Product Management, Operations, Clinical, Manufacturing, and R&D functions to ensure design inputs and outputs meet regulatory, quality, customer, patient, user, and business needs.
• Sponsor a Systems Engineering community of practice, bringing industry best practices, training, standards awareness, and engagement with the broader systems engineering community (INCOSE, AAMI, MDIC, etc).
• Support regulatory inquiries, audits, inspections, and technical discussions, as required.

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 Connected with deep experience in Systems Engineering across NPI and sustaining/lifecycle in regulated manufacturing environments)
• 8+ years of people leadership managing and developing multidisciplinary engineering teams (Systems Engineering; HW/FW/SW/mechanical integration)
• Expertise in systems engineering best practices: user needs → system/subsystem requirements, architecture, interface definition/control, requirements traceability, and configuration management
• Working knowledge of applicable regulatory standards and requirements, including FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 as applicable
• Experience developing medical device platforms that include hardware, firmware and tools/fixtures that interface with devices and/or data in a safe and secure way
• Proven leadership of system-level risk management and design change execution in medical device development, including hazard analysis, dFMEA/pFMEA/uFMEA, impact assessments, V&V/regulatory strategy alignment, and design transfer support
• Proven ownership of verification strategy and execution, including test planning, protocol/report oversight, coverage and traceability management, and ensuring robust evidence for product releases and design changes
• Strong executive communication and cross-functional leadership, including vendor/partner governance, prioritization across multiple programs, and structured problem-solving (RCA/CAPA support)
• Experience supporting global regulatory submissions and responses, including FDA, EU MDR, and international submissions, with technical content and objective evidence

Qualifications

• Working knowledge of AI-enabled tools and responsible-use practices within FDA-regulated medical device development environments
• Proven track record of delivery excellence; project management and organization skills
• Relevant certifications such as INCOSE ASEP/CSEP/ESEP or Lean/Six Sigma

Skills

• Strategic Leadership
• Technical Expertise
• Collaboration
• Regulatory Compliance
• Change Management
• Project Management

Benefits

• On-site / hybrid / remote work options
• Up to 25% domestic travel, primarily to San Francisco Bay Area or Southern California
• Exempt status under FLSA

Pay

• $182,000.00 - $237,000.00

Schedule

• Exempt