Location - West Chester, PA
This work order involves the following Design support activities. This work order would require an Onsite Mechanical Engineer to support and working alongside the FOD team.
- Support the project management activities of various internal projects by attending meetings, understanding key actions to follow up on, take and publish meeting minutes
- Attend weekly supplier conference calls and represent Technical Operations. Record and understand project team goals then report any Tech Ops actions to Project Owner.
- Review supplier change requests for accuracy and determine impact to Animas product
- Review of supplier IQ/OQ/PQ testing protocols for accuracy
- Preparation of supplier non-conformance investigations forms
- Preparation of supplier related CAPA investigations
- Ability to read and interpret assembly and component drawings
- Own/organize change requests in Enable, collect project documents, route for approval. The ability to track and drive multiple complex change requests for project teams.
- Interaction with cross functional teams to support supplier development and change requests
- The Mechanical Engineer should have Engineering degree with experience in process development, change management, and CAPA/NC investigation for electro mechanical medical devices.
- The ability to drive administrative tasks but to also understand the technical details behind the tasks.
- The person should have working understanding of ISO 14971:2012, ISO 15197:2013, ISO 13485:2012, 21 CFR 820.30 (design control) and other international standards.