Principal Catheter Engineer Job at Gentuity, LLC, Sudbury, MA

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  • Gentuity, LLC
  • Sudbury, MA

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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