Senior Development Engineer (Medical Device)
Watertown, MA /
Research & Development /
Full-time
/ On-site
Are you interested in an engaging job and making a big impact in patient's lives?
Background:
Windgap Medical (Watertown, MA) is a rapidly growing, privately-held pharmaceutical company developing injection devices for self-administration and associated drugs. Windgap’s first product is a novel autoinjector that delivers a proprietary epinephrine formulation for the treatment of anaphylactic shock. This new epinephrine product provides users with a thermally stable drug, smaller device, and simpler use case compared to market competitors. Windgap’s current delivery platform and others in development will be used to expand the company’s portfolio of products.
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.
You will be expected to:
- 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
Requirements:
- 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
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.
Windgap's corporate headquarters are in Watertown, MA. Employees based out of this office must be willing and able to be in the Watertown office when it is safe to do so, per company, State, and Federal COVID-19 guidelines.
Thank you for considering Windgap Medical. We will review your qualifications and contact you if we would like to talk more.
Sincerely,
The Windgap Medical Team
