Job Description

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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