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

MWpNNlRZbGxzNll4U1JWanFVSk44V3Y5VlE9PQ==
  • 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.

Job Tags

Similar Jobs

Do Good Work Corp

Senior Construction Project Manager / Estimator Job at Do Good Work Corp

 ...through closeout: schedule, budget, contracts, and client communication. Partner with superintendents to plan the work, manage subcontractors, and drive field execution. Manage costs and change orders to protect project margins and client trust. Serve as a key... 

Mondo

Data/Business Analyst Job at Mondo

 ...Apply now: Data/Business Analyst, location is Hybrid in Arlington, VA. The start date is April 7 for this 3-month contract position (potential to extend). Job Title: Data/Business Analyst Location-Type: Hybrid in Arlington, VA (first two weeks fully onsite, then... 

GDIT

Java Developer - CBP public trust or Top Secret preferred Job at GDIT

 ...Required Technical Skills: Java developmentexperience, Java 8 and higher, Spring or Angular, SOAP/Rest Security Clearance Level: CBP Public Trust Suitability Required Skills and Abilities: Location: Hybrid US Citizenship Required Ability to obtain a Customs... 

TEKsystems

Data Quality Analyst Job at TEKsystems

 ...Develop data quality and standards: These are based on analytical research to avoid similar problems in the future. These standards...  ...When problems with data integrity are discovered the Data Quality Analyst will analyze and determine the root cause. This may involve working... 

Tillys

Administrative Assistant (Legal) Job at Tillys

 ...online. Position Summary The Administrative Assistant (Legal) will provide essential support to Tillys Director of Legal and...  ...DBA, required filings) Assist with managing legal vendors and billing, and liaise with accounting Help develop legal department processes...