Full Job Description
Medical Device Senior Principal Test Engineer – Ventilation
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- Work with sustaining and new product teams in developing and execution of verification test plans, protocols, scripts, test cases and reports
- Drive quality into the product development process through analysis and timely feedback of test results to the design teams
- Working with the team, manage defect issues working with field correction actions, CAPA, and issue tracking tools such as JIRA and JAMA
- Design test cases to include test methodology, test setups, materials, equipment, test procedure, and requirements acceptance criteria
- Develop test plans, protocols, scripts, test cases, and reports to fully verify product level system requirements, and regulatory compliance requirements for agency standards such as ISO, IEC, and FDA
- Conduct system level software testing, analyze issues, and verify bug fixes
- Document, manage and maintain test records consistent with formal verification process and QMS
- Participate in multi-functional team meetings and design reviews
- Provide test mentorship and direction to technicians and engineers
- Build and validate test fixtures and test systems needed for product design verification
- Solve and support resolution to system operational issues pertaining to software and hardware discrepancies, and interoperability with supplier third-party software
- Minimum BS degree in Electrical/Mechanical/Computer Science or Software related major
- 10+ years of related test experience
- Demonstrated experience in verification testing of microprocessor/software controlled medical devices of high level complexity and sophistication
- Able to work well with global teams, including time-zone flexibility
- An understanding of the Vyaire QMS in particular medical device design controls, and verification process
- Proficient in MS Office, and data analysis using spreadsheets.
- Must be detail oriented with strong data analytic, written and oral communication skills.
- Ability to read and understand ventilator and respiratory devices architectural, user documentation, specifications, and interpret system diagrams, schematics and technical performance specifications
- Able to understand ventilator system technical architecture, engineering fundamentals, including electromechanical, microprocessor, and software driven components and operation
- Able to work as part of an interdisciplinary team, but be self-motivated and be able to self-prioritize critical tasks
- Demonstrate basic understanding of IEC/ISO and FDA compliance standards pertaining to critical care medical devices, basic safety, EMC, patient monitoring sensors, alarms, and biocompatibility
- Basic understanding of the FDA 510(k) and PMA process, MDD, MDR and Vyaire QMS.
- Experience with medical device DHF, risk analysis, requirements traceability, and test method validation is a plus.
- Solid understanding or experience with LabVIEW based ventilator test tools, analytical tools, and automated ventilator test systems are a plus.
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