remote
VP, Regulated Device Engineering - Hims And Hers
Software Engineer
Seeking a VP of Regulated Device Engineering to lead product development and ensure compliance with regulatory standards for health and wellness devices. This role requires strong leadership and expertise in medical device engineering.
About the role
Key Responsibilities
- Lead the engineering team in the development of regulated medical devices from concept to launch.
- Ensure all product development activities comply with relevant regulatory standards, including FDA regulations.
- Establish and maintain robust Quality Management Systems (QMS) for device development.
- Oversee the entire product lifecycle, including design, verification, validation, and post-market surveillance.
- Collaborate with cross-functional teams including R&D, marketing, and operations to achieve product goals.
- Drive innovation and continuous improvement in device engineering processes and technologies.
Requirements
- Proven experience in leading engineering teams for regulated medical device development.
- In-depth knowledge of FDA regulations and international medical device standards.
- Strong understanding of Quality Management Systems (e.g., ISO 13485).
- Demonstrated success in bringing medical devices to market.
- Excellent leadership, communication, and strategic planning skills.
Skills
software developmentsystem designproblem solving