Summary:
Seeking a Senior Systems Verification and Validation (V&V) Engineer. The selected candidate will work as a V&V Lead to coordinate all V&V activities necessary to support the release of new and updated medical devices. Focus will be assessing and testing the requirements of electromechanical medical devices at the part, sub-system, and system level, investigating test issues, and assisting V&V technicians. Examples of electromechanical devices include ventilators, sleep therapy devices, oxygen concentrators, personal wellness devices, and the accessories necessary for proper functionality of these types of devices. Examples of test equipment include TSI Flow Analyzer, Meriam Pressure Analyzer, IMT Analytics Vent Analyzer, Oxigraf Oxygen Analyzer, VI Acoustics Hardware/Software, Cincinnati Sub Zero Environmental Chamber, Thermotron Environmental Chamber, Ingmar Automated Servo Lung.
Roles & Responsibilities:
Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
Interact with cross-functional project teams to provide inputs to project plans and schedules.
Estimate resource needs for project support.
Review requirements and scrutinize for testability.
Develop V&V test plans, test procedures, requirements trace matrices, and test reports.
Assign project tasks and responsibilities to V&V team.
Act as advisor to team to meet schedules and solve technical problems.
Quickly learn to use automated test tools and specialty test equipment; develop and validate Client test methods (TMV, DOE, Gage R&R studies).
Execute test procedures both personally and using test technicians.
Log defects and issues found during V&V activities and track to closure.
Participate in defect review boards.
Perform regression analysis and determine testing associated with design changes.
Plan and facilitate V&V formal technical review and design review meetings.
Provide weekly project status reports.
Prioritize project tasks to complete on schedule while maintaining quality of work.
Work in a team environment; peer review work.
Work on multiple, concurrent projects.
You are a part of:
Our group works closely with the development team throughout the product development process. We play an active role early on in ensuring requirements are complete, unambiguous, and testable, collaborate to develop detailed test plans, and assist with development testing prior to the verification and validation phase. While having our own responsibilities within the group, we look to each other's strengths for support in doing our jobs.
Must Have Qualifications:
Bachelor's degree in an engineering discipline; electrical engineering or mechanical engineer background preferred.
5 years professional experience in the medical device industry. Working knowledge of global medical device regulations, requirements, and standards.
Experience developing V&V test plans, test procedures, requirements trace matrices, and test reports
Experience validating test methods (TMV) using methods such as DOE and Gage R&R
Experience with ventilators, sleep therapy devices, oxygen concentrators, personal wellness devices, and associated accessories
Experience with specialized test equipment such as TSI Flow Analyzer, Meriam Pressure Analyzer, IMT Analytics Vent Analyzer, Oxigraf Oxygen Analyzer, VI Acoustics Hardware/Software, Cincinnati Sub Zero Environmental Chamber, Thermotron Environmental Chamber, Ingmar Automated Servo Lung.
Preferred Qualifications:
Bachelor's degree in an engineering discipline; electrical engineering or mechanical engineer background preferred.
5 years professional experience in the medical device industry.
Working knowledge of global medical device regulations, requirements, and standards.
Experience developing V&V test plans, test procedures, requirements trace matrices, and test reports
Experience validating test methods (TMV) using methods such as DOE and Gage R&R
Experience with ventilators, sleep therapy devices, oxygen concentrators, personal wellness devices, and associated accessories
Experience with specialized test equipment such as TSI Flow Analyzer, Meriam Pressure Analyzer, IMT Analytics Vent Analyzer, Oxigraf Oxygen Analyzer, VI Acoustics Hardware/Software, Cincinnati Sub Zero Environmental Chamber, Thermotron Environmental Chamber, Ingmar Automated Servo Lung.
Date Posted: 20 May 2024
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