Quality Engineer

Job 2765 - Mid-Level Quality Engineer - Contract Location: Minneapolis, Minnesota (Onsite) Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future. About The Role This Design Assurance Engineer will provide support for the review, update, and maintenance strategy for the TheraSphere product within the IOE 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 RD 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 such as 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 systematically 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 and at least 4 years of engineering experience. Self‑motivated with a passion for solving problems and a bias for action. Hands‑on approach to problem solving. Strong communication skills (verbal, written) and organization skills. Ability to effectively work and collaborate in an office/remote environment. Adaptable and effective collaborator in a team environment or in self‑directed work. Sponsorship is not available for this position.

AAP/EEO DFWP.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. #J-18808-Ljbffr Medical Engineering Consultants (MEC)