About this role
Work Flexibility: Onsite
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.
Travel Percentage: 20%