Principal Catheter Engineer
Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
• Lead the design, development, and specification creation for single-use intravascular imaging catheters, components, and related manufacturing methods.
• Lead activities such as program management, usability studies, design reviews, feasibility analysis, technical development, performance testing, and pilot manufacturing process validation.
• Create and review design verification test protocols and reports, design of experiments, and risk management file deliverables such as hazard analyses, FMEAs, etc.
• Work and collaborate cross-functionally with internal and external teams to drive catheter product development, obtain necessary resources, and ensure company objectives are met.
• Lead and mentor other members of the catheter engineering team, providing daily direction as needed during assigned project work.
• Ensure adherence to established design control processes, good engineering practices, and the company quality policy.
Other duties as assigned.
Minimum of 9-12 years of technical design and medical product development experience with a four-year technical degree or 5-8 years with an advanced degree. A working knowledge in the following areas:
• Medical device development with sterile single-use disposables
• Specification development
• Medical device design controls or equivalent via work in highly regulated industries
• Sterilization processes
• CAD design
• Statistical analysis including capability and tolerance analyses
• Catheter manufacturing processes including injection molding, extrusions, RF and ultrasonic welding, adhesives, etc.
• Risk management processes including d/pFMEA, specification traceability, hazards analysis and statistical treatment of risks
• Verification testing
• Analytic approach to design development including first principles analyses, finite element simulations, statistical modeling, etc.
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