Staff NPI Project Engineer
Stryker
- Cork
- Permanent
- Full-time
- Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Will select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
- May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
- Will analyse equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
- Complete capability studies for in process inspection and generate subsequent Inspection documentation.
- Conduct MSA studies for new products and new processes.
- Ensure adherence to GMP and safety procedures.
- Review and approval of validation documentation.
- B.S in Mechanical Engineering or related engineering discipline
- 4 or more years’ experience or a related masters degree.
- Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
- Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
- Excellent analytical skills, ability to plan, organise and implement concurrent tasks.
- Good knowledge of manufacturing processes, materials, product and process design.
- Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
- Certified in validation activities.
- Experience in an FDA regulated or regulated industry beneficial.