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; Related masters degree with 2 or more years of experience or PhD may be desirable.

·        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.

·        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.

·        Certified in validation activities.

·        Green or Black Belt 6 Sigma qualifications an advantage.

·        Experience in an FDA regulated or regulated industry beneficial.

·        High level of PC Skills required.

·        Excellent attention to detail.