Aug 18, 2021

Senior Development Engineer (Medical Device)

  • Windgap Medical, Inc.
  • Watertown, MA, USA
Full time Design Engineering Product Development R&D

Job Description

Job Description:Windgap is looking for a hands-on, experienced Development Engineer to support device testing and development related efforts of mature and emerging products. The candidate should be comfortable with the product development process; specifically, characterization testing, design verification, manufacturing process definition, and associated root cause problem solving of non-conforming product.  Experience working in the medical device field a must.

The Candidate Will:

    • Work on a small development team, in conjunction with internal Operations and Quality partners, to drive a life-changing technology to FDA approval
    • Conduct, document, and present testing of a late-stage development product to ensure functionality and confirm all design inputs are met
    • Generate test plans and either carry out associated test methods or oversee the actions completed by a development partner (CMO/CRO)
    • Oversee and maintain Windgap’s mechanical testing lab and the systems therein
    • Oversee the proper execution of design verification, validation, and reliability as conducted by development partners
    • Interact with other Windgap stakeholders to help define, document, analyze, perform, and interpret tests for products, systems, or components
    • Identify functional problems and aid with root cause analysis to suggests resolutions 
    • Define internal quality control standards and the maintenance of reliability programs 
    • Ensure testing procedures comply with relevant USP, ISO, ASTM and other regulatory standards and FDA guidances
    • Strategize and execute test, beta, and pilot builds, as needed
    • Develop close CMO relationships to allow for efficient inventory tracking, build record approval, and test plan approvals
    • Provide hands-on, troubleshooting, process, and manufacturing support to overcome design hurdles

Relevant Experience:

    • Bachelor’s Degree in Engineering (ME, BME, or similar preferred) 
    • 5+ years work experience in the medical device field
    • Experience formulating and executing documentation to support characterization testing (i.e., test plans, test methods, test notes, and test reports)
    • Experience performing Gage R&R and test method validation using custom fixturing
    • Experience calibrating, validating, and maintaining test equipment, including but not limited to tensile testing, torque testing, drop testing, high speed video, metrology hardware
    • Experience writing and conducting equipment validation protocols for IQ/OQ/PQ
    • Experience testing in conformance with ISO 13485 and FDA 21 CFR Part 820
    • Experience with Minitab and an understanding of relevant statistics for product development required
    • Familiar with all phases of product development lifecycle including concept generation, design, rapid prototyping, manufacturing, verification & validation, qualification, and transfer to production
    • Preferably, experience with risk management in design including FTA, FMEA, and root-cause analysis
    • Preferably, experience with drug/device combination products development
    • Preferably, experience with ISO 11608 and 14971 standards
    • Experience with MS Office, including email, word processing, spreadsheets, and presentation tools and using them to effect in a business environment
    • Some travel may be required

Windgap Medical, Inc. offers a competitive benefits package including, medical, dental, disability, life insurance, 401K savings plan and is EOE/M/F/D/V employer. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

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