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.