| Verification & Validation Engineer at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3108903&uid=0878474ce376448e983fc0ba998a6a9f From: Anchal, Tek Inspirations [email protected] Reply to: [email protected] Job Role : Test / Verification & Validation (V&V) Engineer Location: Plymouth, MN ( Hybrid ) , , , only Vantive Interview: Video Device: PrisMax a complex ICU hemodialysis machine (5 ft tall, electromechanical with motors, pumps, sensors, circuit boards, and molded panels) Primary Responsibilities Develop and execute verification and validation (V&V) test plans, procedures, and test cases at both component and system level Document test execution, generate reports, and release in DHF system Hands-on testing of electromechanical components (motors, pumps, circuit boards, sensors) in the lab Perform informal testing (design analysis, feasibility, robustness) and formal testing (documented for regulatory submission) Conduct system-level testing on complete devices, including: Performance testing (e.g., pump flow rate, sensor accuracy) Compliance testing (e.g., IEC 60601 safety and EMC standards) Environmental testing (e.g., shock, vibration, shipping, storage) User validation simulating ICU nurse or clinician use cases Collaborate with R&D, Systems Engineering, Design, Purchasing, and 3rd-party test labs May build fixtures (electrical, mechanical, or software-based) to support testing Must-Haves Bachelors degree in Electrical, Mechanical, or Biomedical Engineering (Physics or other technical degrees are acceptable with strong experience) 1+ years of hands-on test engineering experience (23 years preferred) Experience with electromechanical systems (NOT just disposables or tubing) Familiarity with lab equipment such as oscilloscopes, multimeters, calipers, pressure and force gauges Experience drafting test protocols, procedures, and reports Ability to trace test cases to requirements Strong problem-solving skills and ownership mentality Nice-to-Haves / Differentiators Prior medical device V&V experience Experience with IEC 60601, EMC, or regulatory testing Familiarity with MicroFocus ALM or other test management systems Basic fixture design (electrical, mechanical, or software-based) Experience leading or owning small technical projects Experience from regulated industries such as aerospace or automotive Soft Skills to Assess Takes ownership of work and drives toward solutions Proactive communicator and collaborator Comfortable working independently and troubleshooting issues Resourceful when facing ambiguity or unclear requirements Team and Work Environment Test Engineering team of ~12, growing to 1520 Sub-teams focus on component verification, system verification, system validation, and compliance Workload is approximately 75% in the lab and 25% documentation May check inventory, coordinate with purchasing, or attend technical reviews Flexible work hours (start anytime between 6 AM9 AM), but presence during core hours is expected As a member of the Vantive 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 Thanks and Regards, Anchal Kumari Technical Recruiter Keywords: access management rlang card Minnesota Verification & Validation Engineer [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3108903&uid=0878474ce376448e983fc0ba998a6a9f |
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| 11:37 PM 04-Feb-26 |