Role: Based in our Stryker Anngrove site in Carrigtwohill, Cork Hybrid Role What you will do: Provide engineering support for New Product Introduction (NPI) process development ensuring that all activities are completed and documented in accordance with Stryker procedures.Coordinate with partners/stakeholders to deliver value to business through opportunity identification, execution, and solution delivery.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.
Work with quality engineers to develop component-specific testing and inspection protocols.Lead/support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation.Analyze equipment to establish operating data, conduct experimental tests, and result analysis.
Lead and/or participate in process review meetings.Participate in PFMEA, Control Plan, SOP, and PPAP generation associated with product 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.Review and approval of validation documentation.Who we want: Analytical problem solvers: People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.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.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 Qualifications: Bachelor's degree (B.S.)
in Mechanical or related engineering discipline required.2+ years of work experience required.Preferred Qualifications: 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 an FDA regulated or ISO 3485 regulated industry - highly preferred.Good understanding of Design for Manufacturing (DFM), related statistical tools, and validation/verification techniques.
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