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Senior Systems V&V Engineer

2 months ago


Fremont, California, United States Info Way Solutions Full time

Job Title: Senior Systems V&V Engineer

Job Summary:

We are seeking a highly skilled Senior Systems Verification and Validation (V&V) Engineer to join our team at Info Way Solutions. As a V&V Lead, you will be responsible for coordinating all V&V activities necessary to support the release of new and updated medical devices. Your focus will be on assessing and testing the requirements of electromechanical medical devices at the system, sub-system, and part level.

Key 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.

Requirements:

* 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.

About Us:

Info Way Solutions is a leading provider of medical device solutions. We are committed to delivering high-quality products and services that meet the needs of our customers. Our team is passionate about innovation and excellence, and we are looking for talented individuals to join us in our mission.