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. 
  • They are currently working on the Machine Prismax
  • It is a mix of formal and informal testing:
    • Formal testing -documentation, release data, reporting
    • Informal testing- try to expose the design reports, not much in documentation, it is also called design and analysis testing.

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
  • Looking for an entry-level test engineer, 3 openings, someone with electromechanical exp, model panels, circuit cards, exp in lab, oscilloscope, mechanical gauges, calipers, motors, pumps, electromechanical devices, 
  • Looking for someone who can develop test cases, test reports, and procedures, draft reports, test plans, conduct assessments on design, execute reports and testing, can perform testing in the lab and draft the reports. 
  • This person could be working on hardware, sound level testing, or multiple testing, IC testing, IC 6601, in-house performance testing in a lab, tracing requirements, traceability to test cases, system validation, and user needs testing. 
  • Apart from testing, they will draft documents, conduct hands-on execution in the lab, prepare testing reports, check inventory for supply, check purchase orders or materials, and might work with system and design engineering. they will work 75% in the lab and 25% in documentation.
  • It is nice to have a design experience, small-level electrical circuits, design software to automate data collection,
  • Non-local are also considered but can relocate on their own, 
  • 10+ years of experience would also be considerable

Must have skills:

  • Engineering degree, electromechanical exp / biomedical/ Electrical eng,/ mechanical eng, some exp in V&V testing 
  • Highlights in resumes- electromechanical devices in test, electromechanical for sure 

Preferred: 

  • Medical device exp
  • As there are 3 openings so some skills can be negotiable 


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

Education

Any Gradute