Design Assurance Quality Engineer

Biomerics LLC•Brooklyn Park, MN

23h

About The Position

The Design Assurance Quality Engineer provides Quality Engineering support for new product development (NPD) projects from concept through design transfer and commercialization, while also supporting sustaining engineering activities for existing products throughout their lifecycle. This position partners with Design Engineering, Manufacturing Engineering, Operations, Supplier Quality, Business Development, and Quality to ensure customer, quality, and regulatory requirements are appropriately incorporated throughout product development and ongoing product support. The Design Assurance Quality Engineer supports design controls, risk management, verification and validation, supplier and material qualification, design transfer, and product/process change activities in accordance with the Quality Management System (QMS) and applicable regulatory requirements.

Requirements

Bachelor’s degree or technical degree in Engineering or a related technical field; equivalent education and experience may be considered.
Minimum of 5 years of experience in a medical device manufacturing, product development, Quality Engineering, or related regulated environment.
Working knowledge of applicable FDA Quality System requirements, ISO 13485, and ISO 14971.
Experience with medical device design controls and new product development processes.
Experience with product and process verification and validation activities, including protocol development and execution.
Experience with DFMEAs, PFMEAs, and Risk Management activities.
Understanding of design transfer, manufacturing processes, production readiness, and sustaining engineering activities.
Strong project management and organizational skills with demonstrated initiative in taking ownership of and completing assigned projects.
Strong verbal and written communication skills, including the ability to effectively document technical and quality activities.
Ability to work effectively within cross-functional project teams.
Ability to manage and prioritize multiple projects, objectives, and deadlines in a fast-paced environment.
Strong analytical and problem-solving skills with attention to detail.

Responsibilities

Execute design, development, and validation activities throughout the product life cycle in accordance with project scope.
Utilize the Design Control process to create cost-effective and efficiently manufacturable products.
Contribute to deliverables in compliance with MDR, ISO, and EN standards.
Translate customer specifications and requirements into clear, concise performance and functional requirements.
Conduct engineering evaluations, characterizations, design of experiments (DOE), bench testing, and other verification activities to improve and confirm design and process capabilities.
Train and guide development technicians/operators in hands-on prototyping, testing, and process development.
Execute document change requests and effectively train development/production operators and technicians on updated documentation.
Design, procure, install, qualify, document, and train on new tooling/fixturing.
Evaluate and implement new technologies and ideas for product improvement.
Use statistical tools to analyze data and make development decisions to enhance process capability.
Develop and refine manufacturing procedures and test/inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.