- Validation Engineers will provide support to calibrate manufacturing equipment, perform validation tests such as IQ/OQ/PQ on machinery and equipment, analyze those results and correct any quality issues
- Will provide Validation Engineering support and will be responsible for the Initial design of facility projects and to reach agreement on any additional required modifications.
- Will provide any Other Validation Engineering support as required for each assigned process.
- Work will follow procedural/process guidelines to ensure consistency in deliverables.
- The duration of the engineering work is dependent upon input from support groups (i.e. Manufacturing, Engineering, QA document review, etc.); therefore, the Davis consultant will work with all groups to ensure timelines are met. Circumstances where timelines may be jeopardized will be reported to management for assistance in getting the expected results.
- Bachelors of Engineering required from a 4 year university with a preference to candidates holding an advanced educational degree (Masters or Doctorate)
- Previous Medical Device Manufacturing experience preferred
- 3-5 years of ISO 13485 documentation and validation experience (preferably in a medical device manufacturing facility
- Experience in development and execution of qualification/validation protocols for machinery and processes
- Ability to identify, investigate and resolve production yield issues, nonconformances or equipment reliability issues