Principal Catheter Engineer

3 weeks ago

Greater Sudbury, Canada Gentuity Full time

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 devices, components, and related manufacturing methods with internal and external partners.
• Lead activities such as, design reviews, feasibility analysis, performance testing, and pilot manufacturing process validation.
• Work and collaborate cross-functionally with internal and external teams to drive product development, obtain necessary resources, and ensure company objectives are met.
• Create and review design verification test protocols and reports, design of experiments, and risk management file deliverables such as hazard analyses, FMEAs, etc.
• Lead and mentor other members of the 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.

EXPERIENCE/EDUCATION/SKILL REQUIREMENTS:

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
• Management of external partnerships for development and manufacturing
• CAD design and specification development
• Medical device design controls or equivalent via work in highly regulated industries
• Sterilization processes
• Statistical analysis including capability and tolerance analyses
• Catheter, balloon, and guidewire manufacturing processes including injection molding, extrusions, RF and ultrasonic welding, adhesives, laser processing, etc.
• Risk management processes including d/pFMEA, specification traceability, hazards analysis and statistical treatment of risks
• Leadership/mentorship
• Verification testing
• Analytic approach to design development including first principles analyses, finite element simulations, statistical modeling, etc.

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