Impactful Design Assurance Engineer - Medical Devices

Socket.dev; Brooklyn Park (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Biomerics in Minnesota is seeking a Design Assurance Quality Engineer to drive quality engineering for new product development and sustaining activities. You will partner with Design Engineering, Manufacturing, Operations, Supplier Quality, and Quality to ensure regulatory requirements are incorporated from concept through design transfer.

The role focuses on design controls, risk management, verification/validation, and change management, with responsibility to train teams, support CFR 21 Part

Qualifications

• Bachelor’s degree or technical degree in Engineering or related field.
• Minimum 5 years in a medical device manufacturing or regulated environment.
• Experience with FDA QMS requirements, ISO 13485, ISO 14971.
• Experience with design controls and new product development processes.
• Experience with verification and validation activities, including protocols.
• Experience with DFMEAs and PFMEAs.

Responsibilities

• Execute design, development, and validation activities throughout the product life cycle.
• Utilize the Design Control process to create manufacturable products.
• Contribute to deliverables in compliance with MDR, ISO 13485, and EN standards.
• Translate customer requirements into performance and functional requirements.
• Conduct evaluations, DOE, bench testing, and other verification activities.
• Train development and production personnel on updated documentation.
• Support design transfer, tooling, and process validation activities.
• Analyze data with statistical tools to guide decisions.
• Develop and refine manufacturing procedures and test plans.

Skills

Quality Engineering

Project management

Regulatory compliance

Process improvement

Data analysis

Education

Bachelor’s degree in Engineering or related field

Tools

DFMEA

PFMEA

Job description

Biomerics in Minnesota is seeking a Design Assurance Quality Engineer to drive quality engineering for new product development and sustaining activities. You will partner with Design Engineering, Manufacturing, Operations, Supplier Quality, and Quality to ensure regulatory requirements are incorporated from concept through design transfer.

The role focuses on design controls, risk management, verification/validation, and change management, with responsibility to train teams, support CFR 21 Part