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.