Research And Development Engineer - Sudbury, United States - Whitridge Associates
Description
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.