Research And Development Engineer

3 weeks ago


New York, United States Whitridge Associates Full time

• 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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