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Job description
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.
Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements.
Support capital acquisition activities.
Will analyze equipment to establish operating data, conduct experimental test 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.
Be able to read and interpret complex engineering drawings and have the ability to 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
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