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瑞森醫(yī)療(漳州)有限公司

測試工程師(當?shù)豐unrise測試機構(gòu))

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小黃
人事專員?今日活躍  IP屬地:福建

薪資: ¥18000-20000元/月

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要求: 本科 | 經(jīng)驗不限 | 英語 | 年齡不限

地址: 漳州市-長泰區(qū)(古農(nóng)農(nóng)場 銀光路6-2號1#廠房)導(dǎo)航

人數(shù): 招聘1人

時間: 5天/周

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公司簡介

許可項目:第二類醫(yī)療器械生產(chǎn)。(依法須經(jīng)批準的項目,經(jīng)相關(guān)部門批準后方可開展經(jīng)營活動,具體經(jīng)營項目以相關(guān)部門批準文件或許可證件為準)一般項目:第一類醫(yī)療器械生產(chǎn);第一類醫(yī)療器械銷售;第二類醫(yī)療器械銷售;專用設(shè)備制造(不含許可類專業(yè)設(shè)備制造);殘疾人座車制造;殘疾人座車銷售;假肢和矯形器(輔助器具)生產(chǎn)裝配;機械電氣設(shè)備制造;機械零件、零部件銷售;機械設(shè)備租賃;五金產(chǎn)品制造;五金產(chǎn)品批發(fā);五金產(chǎn)品零售;機械設(shè)備研發(fā);金屬制品研發(fā);電子專用材料研發(fā);電機及其控制系統(tǒng)研發(fā);碳纖維再生利用技術(shù)研發(fā);新材料技術(shù)研發(fā);康復(fù)輔具適配服務(wù);模具制造;貨物進出口;助動自行車、代步車及零配件銷售;日用品銷售;租賃服務(wù)(不含許可類租賃服務(wù));互聯(lián)網(wǎng)銷售(除銷售需要許可的商品);信息技術(shù)咨詢服務(wù);市場營銷策劃;技術(shù)服務(wù)、技術(shù)開發(fā)、技術(shù)咨詢、技術(shù)交流、技術(shù)轉(zhuǎn)讓、技術(shù)推廣。(除依法須經(jīng)批準的項目外,憑營業(yè)執(zhí)照依法自主開展經(jīng)營活動)(不得在《外商投資準入負面清單》禁止外商投資的領(lǐng)域開展經(jīng)營活動)
A. POSITION SUMMARY:
The Test Engineer is responsible for the operation and management of the local Engineering Test Lab. The position supports the Sunrise R&D teams around the world by testing medical products according to international standards and proprietary Sunrise test protocols. This includes conducting all necessary testing, writing test reports and product documentation as well as coordinating any external product testing. It includes verification analysis, root cause analysis and problem solving. Interaction with other functional groups, such as Manufacturing, Quality, Purchasing and Product Management is essential. Further responsibilities include coordinating the workflow and priorities of the test lab as well as ensuring all test apparatus is present, functional and calibrated. The test engineer coordinates the timely prototype deliverables for Verification test with internal and external resources. The Test Engineer must comply with Sunrise Medical processes, ISO 13485 Quality Management System and global Regulatory requirements such as CE, EU MDR, UKCA, FDA, TGA, CERAH and others.


B. JOB DUTIES & RESPONSIBILITIES: (Select from the selections below that apply)
Design Tasks
? Apply electrical and mechanical knowledge to conduct product testing according test protocols and standards, this includes both standardized and internally developed test protocols.
? Understand the product Test Plan and ensure Verification and Validation testing is completed in accordance with Test Plan.
? Document the results of the product testing accurately and promptly upon completion of the test.
? Responsible for the proper release of test reports and promptly notifying the responsible engineer of the results.
? Apply analytical capabilities to accurately predict function and service life and/or develop a unique method of testing and evaluation.
? Read and understand design drawings and measure components accordingly.
? Evaluate proper fit/function of build prototypes and serial products.
? Take responsibility for test results.
? Ensure test apparatus is available, properly maintained and calibrated.
? Ensure the facility workflow is properly managed and communicated to the relevant parties.
? Ensure the test lab facility is properly maintained and tidy.
? Ability to assemble and disassemble medical products.
? Other duties as agreed by supervisor.
Implementation Tasks
? Work with the other Engineers, departments, test labs and suppliers to ensure successful project completion and to meet project goals.
? Contribute to the development of internally generated protocols and equipment necessary for confidence tests.
? Adjust, rework and produce as necessary test rigs by either building in-house our out-sourcing.
? Lead the execution and completion of Verification and Validation tests per the Test Plan.
? Perform root cause analysis and evaluation of product quality issues, identify andimplement solutions, and provide feedback into the appropriate process to eliminate future issues.


C. REQUIRED SKILLS, KNOWLEDGE, AND EXPERIENCE:
? Technician or bachelor’s degree in mechanical engineering, Electrical Engineering or related engineering discipline required.
? Experience preferably in medical related field. Minimum of 2 years’ experience.
? Be able to resolve issues in a structured, logical timely manner.
? Able to communicate, read, and write clearly in the English language.
? Able to travel 10% of the time to North America or Europe (passport required).
? Understand principles of testing and measurement.
? Proven ability to manage a test facility.


D. COMPETENCIES:
? Forward Thinking: Anticipate real potential problems (from multiple areas such as design, processes, application, etc.) and enact solutions preemptively.
? Analytical Thinking. Approaching a problem by using a logical, systematic, sequential approach
? Technical Expertise: Demonstrate necessary technical judgment in evaluating new designs or trouble-shooting existing designs.
? Thoroughness: Ensures work is complete, accurate and carefully prepared.
? Fostering Teamwork: Able to work cooperatively and in a constructive manner with other team members\
? Deductive Reasoning: The ability to apply general rules to specific problems to produce answers that make sense.
? Written Comprehension: The ability to read and understand information and ideas presented in writing.
? Thoroughness. Ensures work is complete, accurate and carefully prepared.
? Personal Credibility – Demonstrated concern that one be perceived as responsible, reliable and trustworthy.
.
E. KEY PERFORMANCE INDICATORS
The follow indicators will be measured and are key to assessing job performance:
? Timely and accurate execution of test protocols.
? Timely and accurate completion of test reports.
? Proper function and cleanliness of test facility.

公司地圖

古農(nóng)農(nóng)場 銀光路6-2號1#廠房

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更新于:2024-10-22

瑞森醫(yī)療

瑞森醫(yī)療(漳州)有限公司

第二類醫(yī)療器械生產(chǎn)
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