Overview As Engineering Director, you will shape the engineering strategy and scale manufacturing operations. You will lead product development, sustaining engineering, and technical operations, aligning with regulatory standards to enable a larger manufacturing footprint. You'll drive continuous improvement, partner with R&D, and ensure product quality in a regulated medtech landscape. This is a high-impact role shaping technical foundations and future growth in a mission-driven company.
Compensation / Benefits- health insurance options
- Health Savings Account contributions
- Dental, Vision, Life and Disability benefits
- 401k plan with employer match
- Flexible time off
- Tuition reimbursement
Responsibilities- Develop and execute the engineering strategy aligned with business goals and manufacturing roadmap
- Lead, mentor, and grow a high-performing team across product development, sustaining engineering, test engineering, and technical operations
- Build scalable engineering systems, processes, and documentation for a future manufacturing footprint
- Serve as the technical voice on the leadership team for long-range planning, risk assessment, and scale-up readiness
- Oversee product lifecycle activities including concept, design, verification/validation, risk management, and post-market support
- Lead NPD programs from concept to commercialization in compliance with FDA, ISO 13485 and other regulatory requirements
- Manage sustaining engineering efforts including product enhancements, field issue resolution, cost reductions, and design improvements
- Oversee relationships with contract manufacturers, suppliers, and external development partners to enable transfer-to-manufacturing and quality oversight
- Collaborate with Quality, Regulatory, Program Management, and Clinical teams to ensure safety, performance, and compliance
- Own engineering documentation, design controls, and compliance with FDA QSR, ISO 13485, IEC 60601
Key requirements- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field; Master's preferred
- 10 years engineering experience in the medical device industry
- 5 years in technical leadership roles managing cross-functional teams
- Proven success leading sustaining engineering and/or NPD programs under regulated design controls
- Experience with contract manufacturers and design transfer activities
- Strong understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and V&V methodologies
- Proven ability to build processes, mentor teams, and drive cross-functional alignment
- Strong leadership and people-development capabilities
- Cross-functional collaboration with Operations, Quality, Regulatory, and Clinical teams
- Strategic thinking with risk-aware decision making
- Regulated design controls (FDA QSR)
- ISO 13485 quality management and risk management (ISO 14971)
- V&V methodologies
