Katalyst Healthcares and Life Sciences
Responsibilities:
- The basic function of this position is to author technical change assessment related to medical devices and to provide support to customer complaints - including ensuring the root cause appropriately.
- Consider the device and device constituents, author technical and risk assessments related to the device design change, and document the device risk analysis from complaints.
- Team supports multiple Medical Device and Combination Products (MDCP), such as vaccine prefilled syringes and devices.
- Bachelor's 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 documentations 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.
- 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.
- Preferred skillsets- Medical device combination product background/experience, understanding root cause, deviation management and change management.