Design Quality Engineer
Listed on 2026-07-19
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Engineering
Quality Engineering
Design Assurance Engineer
Duration: 12 Months Contract (Possible Extension)
About the role:
This Design Assurance Engineer will provide support for the review, update, and maintenance strategy for a product within the IO&E division. In this position you will work with a cross-functional team to support the commercialized medical device and ensure the safety, quality and compliance of the product by reviewing and maintaining the design control deliverables and risk management activities.
Your responsibilities will include:
- Support the review of verification and validation activities and strategize/execute any required updates/testing to meet or exceed internal and external requirements
- Review, update, and maintain the Design History File and work with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
- Work within a cross-functional team to review, identify and implement updates and effective controls.
- Review, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
- Review, update, and maintain the usability file: plan, participate in usability assessments, and generate/update usability documentation
- Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process.
- Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, with guidance/collaboration of the team.
Minimum Qualifications
- Bachelor's degree in biomedical engineering, Mechanical Engineering or related field of study
- 4+ years of experience in engineering
Note:
- Hybrid - days day onsite/ Arbor Lakes (MG)
- Local candidates will be considered first-
- Interviews - possibly 2 teams video interviews.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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