Medical Device Design Assurance Engineer

Biomeric; Brooklyn Park (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical/Dental/Vision Insurance

Short-Term Disability

Long-Term Disability

Life Insurance

Paid Vacation Days

Paid Holidays

401k

Job summary

Biomerics, a leading medical device manufacturer, seeks a Design Assurance Quality Engineer to drive QMS-aligned design controls and V&V through NPD and sustaining activities. You will partner with Design Engineering, Manufacturing, Operations, Supplier Quality, and Quality to ensure regulatory requirements are met.

The role supports design transfer, risk management, and process improvements across lifecycle stages, ensuring product quality from concept to commercialization in a fast-paced

Qualifications

• Bachelor’s degree in Engineering or related field.
• 5+ years in medical device manufacturing or regulated environment.
• Working knowledge of FDA Quality System requirements, ISO 13485, 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.

Responsibilities

• Execute design, development, and validation activities throughout the product life cycle.
• 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 performance and functional requirements.
• Conduct engineering evaluations, characterizations, DOE, bench testing, and other verification activities.
• Train and guide development technicians/operators in prototyping, testing, and process development.
• Execute document change requests and train development/production operators 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.

Education

Bachelor’s degree in Engineering or related field

Job description

Biomerics, a leading medical device manufacturer, seeks a Design Assurance Quality Engineer to drive QMS-aligned design controls and V&V through NPD and sustaining activities. You will partner with Design Engineering, Manufacturing, Operations, Supplier Quality, and Quality to ensure regulatory requirements are met.

The role supports design transfer, risk management, and process improvements across lifecycle stages, ensuring product quality from concept to commercialization in a fast-paced