史赛克 · 全球质量和生产运营

Senior Engineer, Product transfer

薪资面议  /  苏州

今天 16:38 更新

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公司简介

史赛克

"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。"

职位属性

招聘类型:社招
工作性质:全职

职位描述

·        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.

 

 

任职条件

·        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.