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.
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
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.
Metrology
Risk management processes including d/pFMEA, specification traceability, hazards analysis and statistical treatment of risks