公司简介
"史赛克是世界上领先的医疗技术公司之一。 在全球75个国家和地区,我们与客户精诚合作,致力于提高医疗保健水平。"
"史赛克是世界上领先的医疗技术公司之一。 在全球75个国家和地区,我们与客户精诚合作,致力于提高医疗保健水平。"
· 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.
· 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.
· 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.