Staff Engineer, Advanced Operations

23 month fixed term hybrid role based in Carrigtwohill, Cork

Responsible for creating a work practice and environment that pushes the boundaries of conventional manufacturing & metrology.  Role success will be gauged by this individual’s contribution in coaching the engineering team to effectively meet and/or exceed new product metrics including product cost, process performance and time to market.

Responsibilities

• 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 analyze 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.
• Provides on-going status reports including periodic reviews progress and evaluation of results to management.
• 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, SOE/MAP and PPAP generation associated with product transfers and launches.
• Ensure adherence to GMP and safety procedures.
• Operates with appreciable latitude for unreviewed action or decision.
• Review and approval of validation documentation.

Qualifications/Work Experience Preferred

• 4 or more years’ experience
• 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 recognize 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, organize 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.
• familiar with validation activities.
• Experience in an FDA regulated or regulated industry beneficial.
• Excellent attention to detail.