Lead Engineer - Process Development,

Lead Process Development Engineer (Snr Staff)

Division: Stryker Instruments, NPI

Location: Carrigtwohill

Role: Hybrid

Position Summary

Responsible for creating a work practice and environment that pushes the boundaries of conventional manufacturing.

Key Areas of Responsibility

• Determines the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment.

• Will monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures.

• Lead capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.

• Will analyse equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings.

• Will coach and mentor others on functionally related topics.

• 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 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.

• Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.

• Ensure adherence to GMP and safety procedures.

• Review and approval of validation documentation.

• All other duties as assigned.

Qualifications Knowledge Skills

• B.S in Mechanical Engineering or related engineering discipline with 6 or more years’ experience

• Proven track record of working in a team based environment.

• Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognise good ideas.

• Innovative thinker - should be able to envisage new and better ways of doing things.

• Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.

• Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.

• Excellent analytical skills, ability to plan, organise and implement concurrent tasks.

• Excellent working knowledge of manufacturing processes, product/process design and engineering materials.

• Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.

• Green or Black Belt 6 Sigma qualifications an advantage.

• High level of PC Skills required.

• Excellent attention to detail.

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