Wednesday, 14 January 2015

Change Management - Mechanical engineer


Location - West Chester, PA
1.    Scope
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 

2. Skills required to take this Work Order
  • 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.