Senior R&D Engineer

Gentuity • Sudbury, MA

2d

About The Position

Makes significant contributions to the design, development, and specification creation for single-use intravascular devices, components, and related manufacturing methods with internal and external partners.
Lead and/or support 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.
Support the creation and review of design verification test protocols and reports, design of experiments, and risk management file deliverables such as hazard analyses, FMEAs, etc.
Ensure adherence to established design control processes, good engineering practices, and the company quality policy.
Other duties as assigned.

Requirements

• Minimum of 6+ years of technical design and medical product development experience with a four-year technical degree or 2-4 years with an advanced degree.
• 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.

Responsibilities

• Design, development, and specification creation for single-use intravascular devices, components, and related manufacturing methods with internal and external partners.
• Lead and/or support 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.
• Support the creation and review of design verification test protocols and reports, design of experiments, and risk management file deliverables such as hazard analyses, FMEAs, etc.
• Ensure adherence to established design control processes, good engineering practices, and the company quality policy.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level