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Job Title:
Process Development Engineer (Staff)
Reports To:
Associate Manager
Contract Details:
23-month Fixed Term Contract based in Carrigtwohill, Cork, Ireland
Position Summary
Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity. Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines, and product costs. Builds productive internal and external working relationships and may periodically provide guidance and train other team members.
Key Areas of Responsibility
* 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.
* Select components and equipment based on analysis of specifications, reliability, and regulatory requirements. Collaborate with quality engineers to develop component-specific testing and inspection protocols.
* Lead/support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation.
* Analyze equipment to establish operating data, conduct experimental tests, and analyze results. Lead and/or participate in process review meetings.
* Participate in PFMEA, Control Plan, SOP, and PPAP generation related to product transfers and launches.
* Complete capability studies for in-process inspection and generate subsequent inspection documentation.
* Conduct MSA studies for new products and processes.
* Provide training for manufacturing team members.
* Ensure adherence to GMP and safety procedures.
* Review and approve validation documentation.
* Perform all other duties as assigned.
Required Skills
* B.S. in Mechanical Engineering or related engineering discipline with 4 or more years of experience.
Preferred Skills
* Proven track record of working in a team-based environment.
* Excellent interpersonal skills—able to express ideas and collaborate effectively with multidisciplinary teams. Be open-minded with the ability to recognize good ideas.
* Innovative thinker—should be able to envisage new and better ways of doing things.
* Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgment for mechanical and structural design.
* Good understanding of Design for Manufacturing (DFM), related statistical tools, and validation/verification techniques.
* Analytical skills, with the ability to plan, organize, and implement concurrent tasks.
* Good 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 validation activities.
Additional Information
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Engineering and Information Technology
* Industries: Medical Equipment Manufacturing
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