Senior Project Engineer

2 weeks ago


Cork, Ireland Stryker Group Full time

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.

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