小黄 刚刚活跃
瑞森医疗（漳州）有限公司 • 人事专员
工作天数：5天/周
职位描述
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.
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.
工作地址
古农农场 银光路6-2号1#厂房
更新于 2024-11-18
