Description
The primary objective of this role is to advance HF-OCT catheter products through the product development lifecycle, from concept and design through verification, design transfer, and commercialization, resulting in best-in-class clinical and technical performance.
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
• Makes significant contributions to the product development of single-use intravascular devices, components, and related manufacturing methods with internal and external partners.
• Lead and/or support activities such as, design optimization, verification and validation testing, and design transfer.
• Drive technical decision making with internal and external teams, resolving design, manufacturing, supplier, and testing challenges as they arise, to ensure successful product development and company objectives are met.
• Support the creation and review of design verification test protocols and reports, design of experiments, and risk management file deliverables such as hazard analyses, FMEAs, etc.
• Ensure adherence to established design control processes, good engineering practices, and the company quality policy.
Other duties as assigned
Requirements
Minimum of 8+ years of technical design and medical product development experience with a four-year technical degree or 4-6 years with an advanced degree. A working knowledge in the following areas:
· Experience developing single use medical devices through design verification, validation, design transfer, and commercial release.
· Management of external partnerships for development and manufacturing
· Development of engineering drawings, specifications, tolerance analyses, and manufacturing documentation.
· Medical device design controls or equivalent via work in highly regulated industries
· Risk management processes including d/pFMEA, specification traceability, hazards analysis and statistical treatment of risks
· Development and execution of verifications strategies, test methods, protocols, statistical justifications, and technical reports.
· Application of statistical methods to verification planning, capability assessment, tolerance allocation, and design decision making.
· Catheter, balloon, and guidewire manufacturing processes including injection molding, extrusions, RF and ultrasonic welding, adhesives, laser processing, etc.
· Leadership/mentorship
· Analytic approach to design development including first principles analyses, finite element simulations, statistical modeling, etc.
Skills Required
- 10+ years of experience in medical device development and testing
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field
- Proven experience with Class II medical devices regulated under FDA and ISO 900/9001, ISO 13485
- Hands-on experience with electromechanical, optical, or fluidic medical systems preferred
- Experience with CAD design
- Working knowledge of basic statistics
- Experience with data acquisition and analysis systems (Minitab, MATLAB) is a plus
What We Do
Gentuity is a commercial-stage medical technology company pioneering next-generation intravascular imaging devices, specifically high-frequency OCT, to provide interventional cardiologists with complete vessel visualization and real-time insights for optimizing PCI procedures.
