Our client, a medical device company in Canada are looking to recruit a Staff Process Engineer for their site.
The Staff Process Engineer is responsible for the design, development, validation, verification and implementation of new and revised manufacturing lines or integrated system of manufacturing processes.
They are a key member of the product realization teams to ensure product manufacturability and successful transfer to production. They plan for all project activities, participate in the project scope and target definition as related to the manufacturing.
They are expected to prepare documentation in accordance with the Quality Management System, additionally developing novel manufacturing methods and new best practices.
- Adhere to all requirements of the Quality Management System
- Demonstrate values, works with integrity and a supportive corporate member
- Member of a product development team as lead manufacturing line designer
- Responsible for or author design input and output documentation for a manufacturing line.
- Conduct and maintain process risk assessment activities (including PFMEA's) in order to identify critical process parameters and develop appropriate control plans to mitigate risks.
- Develop Validation Plans, protocols and process controls
- Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions
Required skills and courses:
- Bachelor's degree in Engineering
- Minimum 5-7 year related working experience
- Experience in process design/development and product design for manufacturability in the medical device industry, specifically catheter manufacturing
- Experience with extrusion of medical devices
- Good working knowledge of medical device manufacturing requirements and FDA/ISO compliance guidelines
- Experience in process validation, process FMEA and project management
- Experience in Lean manufacturing principles
- Excellent analytical and communication skills (both written and oral)
- Organization and time management skills
For further information on this Staff Process Engineer role in Canada please contact Anne Gough on 0212066287 / firstname.lastname@example.org
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