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:
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 in the lab and at third party medical device test labs communicate all defects/issues/failures during the test .
Under supervision develop and implement feasibility and characterization testing on designs.
Analyze test data for conformance to predetermined 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.
Requirements:
Bachelors 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 handson 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 fastpaced environment where small teams share a broad variety of duties.
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