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Senior Project Engineer, Advanced Operations
1 month ago
Senior Process Development Engineer - Trauma & Extremities Division
Hybrid role, 3 days on site in Cork
What you will do:
- 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.
- Assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements.
- Support capital acquisition activities.
- Analyze equipment to establish operating data, conduct experimental tests, and result analysis. 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.
- Provide training for manufacturing team members.
- Ensure adherence to GMP and safety procedures.
- All other duties as assigned.
Required Qualifications
B.S in Mechanical Engineering or related engineering discipline.
Self-starter with demonstrated efficient work methods, analytical & problem-solving skills, and ability to handle multiple tasks.
Preferred Experience
- Strong communication skills with the ability to effectively work cross-functionally and externally as required.
- Basic knowledge of manufacturing processes, materials, product, and process design.
- Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing.
- Experience in an FDA regulated or regulated industry beneficial but not essential as training is provided.
- High level of PC skills required.
- Excellent attention to detail.
