Director of Engineering

Director of Engineering & New Product Development – Class II/III Medical Devices

We are a fast-growing medical device company dedicated to developing innovative Class II and III devices that improve patient outcomes. We are seeking a Director of Engineering & NPD to lead our product development and engineering teams, from concept through commercialization.

The Director of Engineering & NPD will own the full lifecycle of product development
, guiding cross-functional teams through design, prototyping, verification/validation, and scale-up. This role will define the engineering strategy, ensure compliance with regulatory requirements, and drive innovation in alignment with company goals.

• Lead, mentor, and develop the engineering and NPD teams, fostering innovation and accountability.
• Oversee new product development from concept to commercialization, including design controls, risk management, and regulatory compliance.
• Collaborate closely with R&D, Quality, Manufacturing, and Regulatory Affairs to ensure seamless product transfer and launch.
• Drive engineering strategies for product innovation, design optimization, and manufacturing scalability
  .
• Establish and maintain processes for design verification, validation, and testing
  , ensuring compliance with FDA, ISO 13485, and internal quality standards.
• Identify emerging technologies and opportunities to improve product performance, reduce costs, and accelerate time-to-market.
• Provide technical leadership for troubleshooting, sustaining engineering, and continuous improvement initiatives.
• Manage budgets, resources, and timelines for multiple concurrent projects.

• Bachelor’s degree in Engineering or related field; advanced degree preferred.
• 10+ years of experience in medical device engineering, with at least 5 years leading NPD/engineering teams
  .
• Demonstrated experience with Class II/III medical devices
  , design controls, and regulatory submissions.
• Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and risk management processes
  .
• Proven track record of bringing multiple products from concept to commercialization.
• Excellent leadership, cross-functional collaboration, and project management skills.
• Strong problem-solving and communication abilities to influence at all levels of the organization.

• Lead engineering and innovation for a high-growth, mission-driven company.
• Direct impact on product strategy and patient outcomes.
• Collaborative environment with opportunities to shape the future of medical device development.