Medical Device Engineer - MDE1002

Duration: 12 Months

Job description:

• The basic function of this position is to author technical content related to medical devices and to provide support to customer complaints – including ensuring the root cause appropriately considers the device and device constituents, author technical and risk assessment related to the device design change, and document the device risk analysis from complaints.
• The team supports multiple Medical Device Combination Products (MDCP), such as vaccine prefilled syringes and devices.

• The candidate will work with a small team that supports life-cycle management activities of medical device combination products.
• Demonstrated interpersonal skills including flexibility and ability to work in a team environment.
• Proven problem-solving abilities. Demonstrated written and verbal communication skills.

Education:

• Bachelors in Science, Engineering or related field.
• Can be a mix of Co-op and real-world experience (3-5+ years).
• Has experience in authoring design control documents per 21 CFR 820.30 or device risk document per ISO 14971.
• Demonstrated interpersonal skills including flexibility and ability to work in a team environment.
• Proven analytical abilities. Work requires experience in engineering change assessment, root cause investigations
• and device risk document management.

Preferred skillsets:

• Medical device combination product background/experience.
• Understanding root cause, deviation management and change management.