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Test Engineer
1405 Xenium Ln N Suite 150 Plymouth MN USA 55441 Plymouth, MN 55441 US
Job Description
Job Description:
As a member of the Acute Therapies Verification and Validation engineering team, you would be responsible for supporting product verification, validation, and compliance test activities on electrical and mechanical medical device components/systems. Your expertise will be applied to all levels of product development from component prototypes to final system design. This will include developing, executing, and validating test methods/creating associated documentation. Interface with/support different groups, e.g., R&D, Project Management, Quality, and manufacturing.
Responsibilities include but not limited to:
• Under supervision, Develop/execute verification test methods, protocols, and reports for verification of requirements on components and systems
• Drive quality into product development through analysis, test, and timely feedback of test results back to team
• Under supervision, Design test cases to include test methodology, test setups, materials, equipment, procedure, and acceptance criteria based on requirement and standard
• Execute functional testing of mechanical assemblies, electrical circuits, and systems
• Support hardware team in product development, concept feasibility, pre compliance and change activities by developing test, collecting, and providing test data
• Under supervision, design hardware and/or software tools and fixtures used to execute test methods and analyze data
• Review, understand and characterize electrical/mechanical designs to develop test methods and ensure coverage of requirements
• Read/understand medical compliance standards and requirements, evaluate risk, and develop test procedures to ensure requirements are met
• Perform hands on test execution in the lab and at third party medical device test labs, communicate all defects/issues/failures during the test execution.
• Under supervision, develop and implement feasibility and characterization testing on designs
• Analyze test data for conformance to pre-determined acceptance criteria and record clearly results in testing platforms like ALM.
• Collaborate with System team to better understand requirements and improve test effectiveness.
• Actively participate in improving existing testing scenarios and test cases.
• Maintain laboratory equipment and inventory levels for laboratory supplies
• Perform troubleshooting, hands on rework and calibration of electromechanical Systems
What you'll bring:
• Bachelor's degree in Engineering with 1+ years of experience
• Experience with system and component level electromechanical V&V testing, plans/procedures/reports, equipment, and test methods preferred
• Demonstrated results in both Troubleshooting/resourcefulness; use own expertise/guidance from others to identify/resolve critical issues. Understanding/application of root cause analysis methods.
• Knowledge of electrical/mechanical engineering disciplines with ability to read, understand and analyze electrical schematics/ mechanical drawings
• Experience using electrical/mechanical lab equipment. e.g., oscilloscope, DMM, power supply, force/pressure gauge, caliper, thermometer, flow meter and scales
• Takes a hands-on approach to testing, fault diagnosis and isolation
• Experience creating detailed, clear, and complete documentation and records
• Demonstrated experience collaboratively and effectively across disciplines/project teams
• Comfortable/effective in a fast-paced environment, where small teams share a broad variety of duties
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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