Director, Device Engineering
Leads multidisciplinary hardware and systems engineering team to manage full lifecycle of FDA-regulated wearable EEG medical devices, from concept to commercialization and sustaining support. Requires 10+ years experience in regulated device development, 5+ years people management, and deep expertise in wearables and embedded systems.
Responsibilities
- Lead and scale a multidisciplinary engineering team spanning hardware and systems engineering.
- Own the end-to-end lifecycle of home sleep testing products, from concept and architecture through verification, regulatory submission, manufacturing transfer, commercialization, and sustaining engineering.
- Ensure delivery of safe, reliable, high-quality medical devices that meet clinical needs, regulatory requirements, and business objectives.
- Oversee ongoing product support and improvement efforts, including vendor and contract manufacturer management, production and post-production issue resolution, yield improvement, and design enhancements.
- Partner with QA, RA, Clinical Operations, and Logistics functions to maintain design controls, risk management, and audit readiness.
- Mentor and coach engineers, strengthening technical depth in hardware design, systems integration, verification & validation, and regulated product development.
- Guide architectural decisions, risk management, and trade-offs for new product introduction and manufacturing scale-up.
- Lead creation and review of design control artifacts for regulatory compliance.
Requirements
- Education: Bachelor’s degree in Engineering or related technical field required; advanced degree (MS or PhD) preferred.
- Experience: 10+ years post-graduate experience leading hardware or device engineering teams, delivering FDA- and/or CE-regulated products from concept through commercialization; at least 5 years direct people management.
- Deep technical expertise in wearable devices and embedded systems.
- Fluency in medical device regulations: FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, design control best practices.
- End-to-end product lifecycle and manufacturing experience: EVT/DVT/PVT builds, manufacturing transfer, DFM optimization, supplier qualification, yield improvement, root cause analysis, mass production ramp.
- Strategic and hands-on leadership, cross-functional influence, communication skills.
- Experience in dynamic environments like startups preferred.
Compensation
Salary range: $200,000–$215,000 base, plus equity, PTO, and other benefits.
Senior Suspension System Engineer
Lead design, integration, and validation of an active suspension system for Zoox's autonomous Robotaxi. Requires strong vehicle dynamics, model-based systems engineering, and automotive functional safety experience.
Director, Structures - Design
Lead the aerostructures organization for the X-BAT autonomous aircraft program, overseeing design, analysis, integration, testing, and certification of composite and metallic primary structures from prototype through production. Requires 12+ years aerospace structural engineering experience with proven team leadership and the ability to obtain a U.S. security clearance.
Director, Structures Engineering
Lead the aerostructures organization for the X-BAT autonomous aircraft program, overseeing design, analysis, integration, testing, and certification of composite and metallic primary structures. Requires 12+ years aerospace structural engineering experience and proven team leadership.