Work Flexibility: Hybrid or Onsite
Senior Project Engineer - (Foot & Ankle, NPI)
Role: Based in our Stryker Anngrove site in Carrigtwohill, Cork
Hybrid Role
What you will do:
As a Sr. Project Engineer you will provide engineering support for New Product Introduction (NPI) process development ensuring that all activities are completed and documented in accordance with Stryker procedures.
Additional responsibilities:
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Coordinate with partners/stakeholders to deliver value to business through opportunity identification, execution, and solution delivery
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Ensure quality of process and product as defined in the appropriate operation and material specifications
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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.
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May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
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Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
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Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product launches.
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Complete capability studies for in process inspection and generate subsequent Inspection documentation.
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Conduct MSA studies for new products and new processes.
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Provide training for manufacturing team members.
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Ensure adherence to GMP and safety procedures.
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Review and approval of validation documentation.
Who we want:
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Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
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Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Minimum Requirements:
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Bachelor’s degree (B.S.) in Mechanical or related engineering discipline required
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2+ years of work experience required
Preferred Qualifications:
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Good knowledge of manufacturing processes, materials, product, and process design
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Project Management experience
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Ability to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing
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Experience in an FDA regulated or ISO 3485 regulated industry- highly preferred
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Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
Travel Percentage: 20%
