Staff Engineer, AO 先期运营主管工程师

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 RESPONSIBILITIES:

?The staff engineer will provide technical leadership for the facility. They will be a Subject Matter Expert in a Technical, engineering, automation or Business Process area .This will involve working closely with the site management team to develop and deliver the sites future state strategy.
?Contribute and input into Engineering functional strategy
?Champion operations excellence across the site.
?Benchmark best practices across the Stryker network
?Plans and conducts engineering research design
?Plans and conducts significant engineering and lean initiatives
?Standardizes best practices and procedures across the network.
?Communicates with business partners to resolve process and product issues.
?Provide support to Process Development / Advanced Operations on technology development and application within the manufacturing process.
?Technical leader from a site functional perspective.
?Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.
?The primary objective of this position is to work on the new product introduction projects to achieve excellent quality, delivery and cost goals.
?Work with the divisional R&D team, Advanced Operations team of other Stryker Sites, and local project team to lead or support on the execution of new product introduction project tasks.
?Will aid in the new product development process, from concept to launch, by identifying effective and efficient assembly techniques and manufacturing processes to be used.
?Designs and/or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment.
?Analyzes reports and/or returned products and recommends corrective action.
?May interact with customers to solve reliability issues and/or answer general product questions.
?May work from verbal and/or written instructions.
?May train others in quality assurance/GMP related topics.
?Develop and execute process and product protocol.
?Develop statistical process controls and analyze data. Optimize operating parameters.
?Lead, monitor and control progress of projects to ensure sound application of engineering principles used, and design intent is being achieved.
?Select, analyze, design and improve mechanical and electrical manufacturing procedures and engineering systems for medical devices.
?Verify that new engineering devices are technically sound and in compliance with FDA and other regulatory bodies.
?Analyze and improve computer test software verification and validation equipment
?Develop the Validation plan for new products and their manufacturing processes.
?Plan and execute process validation protocols including IQ, OQ and PQ.
?Ensure manufacturing documentation and process validation are complete, accurate and within QSR compliance.
?Perform engineering risk analyses to manage technical difficulties encountered with new medical devices.
?Participate and aid in the new product development process by identifying effective test methods.
?Lead the process development (flowchart, logistics, manufacturing sequence, etc.).
?Develop manufacturing processes to increase manufacturing capabilities and lower operational costs.
?Design, build and/or purchase fixtures, equipment, machines and tools as needed to ensure quality products at minimal costs.
?Assist suppliers in resolving manufacturing and quality issues.
?Research academic and industrial literature to continuously improve and increase engineering tools and knowledge used at Stryker Suzhou or other Stryker Divisions.
?Analyze and interpret engineering test data collected during new device testing.
?Interface among multiple departments and teams including R&D, Manufacturing and Quality, vendors and senior managers to ensure specific cost, time and or regulatory standards are met.
?Provide performance feedback on who participate in new product introduction activities based on pre-established performance objectives.








RELEVANT EXPERIENCE



?At least 5+ years related experience, have Stryker working experience preferred

?Experience in developing and working with small group problem solving teams.

?Experience on process development in medical device industry is preferred.
?Experience on process quality and quality assurance is preferred。




EDUCATION


· B.S. in Engineering, or above is preferred.


年薪30-40万