Senior Engineer, Product Transfer

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 with 2 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
• Experience in an FDA regulated or regulated industry beneficial.