Quality Engineer III

About the role

This Design Assurance Engineer will provide support for the review, update, and maintenance strategy for the TheraSphere 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.

Responsibilities

• 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

Requirements

• 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
• Hands-on approach to problem solving
• Strong communication (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