Job description
Position: Associate Engineer
Location: West Point, PA
Duration: 12 Months
Responsibilities:
- The basic function of this position is to support design control activities related to the development and commercialization of medical devices and combination products.
- This includes authoring specifications and technical documentation, leading design verification and validation activities and owning elements of device risk management.
Education:
- Bachelors in Science, Engineering or related field. Can be a mix of Co-op and real-world experience (3-5+ years).
- Demonstrated interpersonal skills including flexibility and ability to work in a team environment. Proven analytical and problem-solving abilities.
- Demonstrated written and verbal communication skills.
- Work requires experience in engineering specification development, change assessments, root cause investigations and device risk management.
- The candidate will work with a small team that supports new product development and commercialization management activities of medical device combination products.
- This role requires strong collaboration with development, quality, procurement departments as well as communication with external suppliers and contract manufacturers.
Heavily Preferred skillsets:
- Medical device background/experience, understanding design control process and change management.
- Has experience in authoring design control documentations per 21 CFR 820.30 or device risk document per ISO 14971:2019.
- Remote but preferred work in eastern time zone.
- Comments/Special Instructions
- Offering design control documentation to the FDA
Can be 100% Remote but east coast hours.
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