
Lead Engineer - Process Development,
About the role
Work Flexibility: Hybrid
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:
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Determines the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment.
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Will monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures.
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Lead capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
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Will analyse equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings.
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Will coach and mentor others on functionally related topics.
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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.
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Ensure quality of process and product as defined in the appropriate operation and material specifications.
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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.
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Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
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Ensure adherence to GMP and safety procedures.
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Review and approval of validation documentation.
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All other duties as assigned.
Qualifications Knowledge Skills:
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B.S in Mechanical Engineering or related engineering discipline with 6 or more years’ experience
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Proven track record of working in a team based environment.
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Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognise good ideas.
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Innovative thinker - should be able to envisage new and better ways of doing things.
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Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
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Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
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Excellent analytical skills, ability to plan, organise and implement concurrent tasks.
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Excellent working knowledge of manufacturing processes, product/process design and engineering materials.
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Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
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Green or Black Belt 6 Sigma qualifications an advantage.
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High level of PC Skills required.
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Excellent attention to detail.
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Travel Percentage: 10%
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