- 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 system, sub-system, and part level.
- Examples include ventilators, sleep therapy devices, oxygen concentrators, personal wellness devices, and the accessories necessary for proper functionality of these types of devices.
- 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 novel 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.
- Bachelors 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 level: Experienced
- Minimum 5 years of experience
- Education: Bachelors (required)
- Professional Engineer
- Verification and Validation (2 years of experience is required)
- Medical Device (2 years of experience is required)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled. -
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Systems test engineer - Pittsburgh, United States - Randstad
Description
job summary:
If you are interested in the below opportunity, kindly reach out to me at or
Seeking a Senior Systems Verification and Validation (V&V) Engineer.
job type: Contract
salary: $ per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
ducation/Experience: