An early commercial stage medical device company located in Orange County is seeking a Senior Director of R&D Engineering to lead new product development and commercialization efforts for their innovative vascular device portfolio. The company recently received FDA 510(k) approval for their first surgical device product and is looking to expand their next-gen R&D portfolio.
This role will entail both hands-on R&D engineering work and R&D program leadership. This individual will direct the R&D program, strategy, and product development process while leading a small cross-functional team. Concept to launch product development expertise for both stent and catheter-based medical devices is required!
- Innovate new product designs and build an intellectual property portfolio with the team.
- Create project plans, manage timelines, and lead a cross-functional team for timely project completion.
- Oversee design history file, including risk analysis, verification, validation testing, and other design-control documents.
- Identify vendors/partners, source components, and manage external partners for cost-effective task completion.
- Procure equipment for product development aligned with company strategy.
- Collaborate to articulate clinical needs, develop specifications, and ensure design outputs meet inputs.
- Ensure manufacturability and scalable processes for designs.
- Develop verification and validation strategy for regulatory approvals.
- Contribute to formulating a long-term strategy for emerging technologies.
Required Experience & Qualifications:
- BS/MS in Mechanical or Biomedical Engineering or similar
- 12-15+ years of industry experience in medical device product development for Class II and Class III devices (cardiovascular/vascular devices)
- Expertise in both stent and catheter device design
- Proven track record of creating innovative medical device designs and intellectual property
- Demonstrated experience leading new device development from concept to successful market launch and commercialization
- Expertise in medical device design control and product development processes including DfM, risk management and FDA regulations.
- Experience driving R&D programs and strategy and managing cross-functional teams
- Experience interacting and working with clinical physicians
- Experience identifying and managing external vendors