Design Assurance Engineer

Location:
Maple Grove, MN 55369

Hybrid Role at Arbor Lakes site

• Thorough understanding of quality systems / design control
• Design Assurance Engineer will provide support for the review, update, and maintenance strategy for the Thera Sphere product within the IO&E division.
• 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.
• 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

• Bachelor’s degree in biomedical engineering, Mechanical Engineering or related field of study
• 4+ years of experience in engineering
• Self-motivated with a passion for solving problems and a bias for action
• Ability to effectively work and collaborate in an office/remote environment
• Proven examples of communication skills
• Adaptable and effective collaborator in a team environment or in self-directed work