Senior Project Engineer, NPI

Stryker Group; Cork; Hybrid; EUR 40,000 - 55,000; Full time

Job summary

A leading medical device company located in Cork is looking for a Senior Project Engineer, NPI to support New Product Introductions. The ideal candidate will have a B.S in Mechanical Engineering or a related discipline with up to 2 years of experience. Key responsibilities include ensuring quality processes, providing engineering support, and executing project elements. Strong analytical and problem-solving skills are essential for success in this dynamic role.

Qualifications

• Self-starter with demonstrated efficient work methods and ability to handle multiple tasks.
• Good knowledge of manufacturing processes and ability to read complex engineering drawings.
• Experience in an FDA regulated industry beneficial.

Responsibilities

• Execute assigned project elements with an emphasis on manufacturing systems.
• Provide engineering support for new product introductions.
• Support capital acquisition activity and conduct analysis.
• Ensure adherence to GMP and safety procedures.

Skills

Analytical skills

Problem-solving skills

Interpersonal Skills

Attention to detail

Innovative thinking

Education

B.S in Mechanical Engineering or related engineering discipline

Tools

PC Skills

Job description

Senior Project Engineer, NPI

Permanent

Hybrid Role

Location: Stryker Anngrove, Carrigtwohill, Cork

Position Summary

Working as part of the Trauma & Extremities team, based in Cork, you will be executing on New Product Introductions (NPIs) alongside external suppliers and our Stryker China facilities. Executes the innovation and development of assigned project elements with an emphasis on the manufacturing process, technology and procedures required for the manufacture of new products.

Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.

What you will do:

• Executes assigned project elements with an emphasis on manufacturing systems and procedures.
• Employ project management best practice to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs
• 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.
• Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
• Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
• Will analyse 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 transfers and 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.
• All other duties as assigned.

What you need:

• B.S in Mechanical Engineering or related engineering discipline with up to 2 years’ experience
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• The individual should enjoy working in a fast paced, dynamic and results orientated team environment.
• Good Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams.
• Innovative thinker - should be able to envisage new and better ways of doing things.
• Good analytical skills, ability to plan, organise and implement concurrent tasks.
• Good knowledge of manufacturing processes, materials, product and process design.
• Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
• Experience in an FDA regulated or regulated industry beneficial.
• High level of PC Skills required.
• Excellent attention to detail.

If you are interested in this role, please apply in confidence.

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This role will be posted for a minimum of 3 days.