Work Flexibility: Hybrid
Senior Engineer, Product Transfer
23 Month Contract
Location: Tullagreen, Carrigtwohill, Cork
Hybrid Position. 2-3 Days Per Week On-Site.
Key Areas of Responsibility:
* Provide engineering support for product transfers ensuring that all activities are completed and documented in accordance with the latest Stryker procedures.
* Determine the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment.
* Monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures.
* Analyse equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings.
* Coach and mentor others on functionally related topics.
* Ensure quality of process and product as defined in the appropriate operation and material specifications.
* 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, PPAP and other Stryker internal process qualification generation associated with product transfers.
* Ensure adherence to GMP and safety procedures.
* Review and approve of validation documentation.
* All other duties as assigned.
Qualifications Knowledge Skills:
* Bachelors degree in an engineering discipline
* 3 or more years' experience in a manufacturing or project environment
* Proven track record of working in a team based environment.
* Excellent 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.
* Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural 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
* Experience of process/ product validations, statistical methods, Process mapping,
* Continuous Improvement and Project / Process Improvement related experience
* Green or Black Belt 6 Sigma qualifications preferred
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Travel Percentage: 10%