Director, Systems Engineering

This role is responsible for leading systems engineering strategy, execution, and organizational capability across medical device development programs, ensuring robust design control and compliance across the product lifecycle.

• Define and execute the Systems Engineering strategy, operating model, and resource planning aligned with product and portfolio priorities
• Lead system-level requirements management, ensuring traceability from user needs through system, subsystem, hardware, software, and verification requirements
• Oversee architecture definition, interface control, risk management activities, and design verification strategies across programs
• Guide cross-functional collaboration with RA/QA, Product, Clinical, Manufacturing, and R&D to ensure regulatory and customer requirements are met
• Drive systems engineering best practices including design controls, configuration management, and lifecycle engineering excellence
• Lead regulatory readiness and support audits, inspections, and submissions aligned with applicable standards such as FDA requirements, ISO 13485, ISO 14971, IEC 62304, and related frameworks

Requirements

The ideal candidate brings extensive experience in regulated medical device systems engineering, strong leadership capability, and deep expertise in translating complex technical and regulatory requirements into scalable product architectures.

• Bachelor’s degree in Systems, Electrical, Biomedical Engineering, or related field; advanced degree preferred
• 15+ years of experience in regulated medical device development, including Class II/III environments and connected systems
• 8+ years of leadership experience managing multidisciplinary engineering teams across systems, hardware, firmware, and software integration
• Deep expertise in systems engineering practices including requirements management, architecture design, interface control, and verification planning
• Strong understanding of risk management tools such as hazard analysis and FMEA, and experience supporting regulatory submissions and audits
• Proven ability to lead cross-functional initiatives, influence executive stakeholders, and drive engineering alignment across complex organizations
• Familiarity with global regulatory frameworks including FDA, EU MDR, and international medical device standards
• Strong communication skills with the ability to present technical strategy and risk at an executive level

Benefits

• Competitive base salary range ($182,000 – $237,000 USD) depending on experience and location
• Equity eligibility and performance-based compensation opportunities
• Comprehensive medical, dental, and vision insurance coverage
• Retirement savings plan with employer contributions
• Flexible remote work arrangement within the United States
• Paid time off, holidays, and parental leave policies
• Professional development and industry engagement opportunities
• Opportunity to work on high-impact healthcare technology improving patient outcomes globally.