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:
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
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.
May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
Will analyze equipment to establish operating data, conduct experimental test 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 Requirements:
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
Project Management experience
Ability to read and interpret complex engineering drawings and have the ability to 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.
Travel Percentage: 20%