Senior Engineer, Product Transfer

Stryker·
Suzhou, China
2mo ago
Full-timeSeniorBachelors

Description

Work Flexibility: Hybrid<p style="text-align:inherit"></p><p style="text-align:inherit"></p><h2>Key Areas of Responsibility</h2><ul><li>Provide engineering support for product transfers ensuring that all activities are completed and documented in accordance with the latest Stryker procedures. </li><li>Determine the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment.</li><li>Monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures.</li><li>Analyse equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings.</li><li>Coach and mentor others on functionally related topics.</li><li>Ensure quality of process and product as defined in the appropriate operation and material specifications.</li><li>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.</li><li>Participate in PFMEA, Control Plan, SOP, PPAP and other Stryker internal process qualification generation associated with product transfers.</li><li>Ensure adherence to GMP and safety procedures.</li><li>Review and approve of validation documentation.</li><li>All other duties as assigned.</li></ul><p></p><p></p><h2>Qualifications Knowledge Skills</h2><ul><li>Bachelors degree in an engineering discipline with 2 or more years’ experience in a manufacturing or project environment</li><li>Proven track record of working in a team based environment.</li><li>Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognise good ideas.</li><li>Innovative thinker - should be able to envisage new and better ways of doing things.</li><li>Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.</li><li>Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.</li><li>Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.</li><li>Experience in an FDA regulated or regulated industry</li><li>Experience of process/ product validations, statistical methods, Process mapping,</li><li>Continuous Improvement and Project / Process Improvement related experience</li><li>Green or Black Belt 6 Sigma qualifications</li><li>Experience in an FDA regulated or regulated industry beneficial.</li></ul><p></p><p></p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: None<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>
Stryker

Stryker

MEDICAL DEVICES

Medical Devices

LocationCA - San Jose
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