Design Quality Engineer

Job Description

The Design Quality Engineer will play a key role in New Product Introduction (NPI), leading quality system and design assurance activities to ensure alignment with FDA 21 CFR Part 820, ISO 13485, and applicable EU Medical Device Regulations for a Class III medical device environment.

Essential Duties and Responsibilities:

• Lead Design Assurance activities throughout the full product lifecycle
• Provide expertise in Risk Management, Design Verification and Validation, Test Method Validation (TMV), Statistical Methods, Process Validation (PV), and other Design Controls
• Apply structured problem-solving methods to address quality and compliance issues
• Stay current on relevant regulatory requirements and industry standards
• Advise and support cross-functional engineering teams
• Contribute to supplier qualification efforts
• Support pilot manufacturing and production setup
• Perform additional duties as assigned

Minimum Qualifications:

• Bachelor’s degree in science or engineering
• 5 years of quality experience in the medical device or life sciences sector
• Experience with U.S. Class III medical devices preferred.

Skills and Abilities:

• Demonstrated leadership capabilities and ability to lead teams toward project goals
• Strong analytical and organizational skills, with the ability to gather and interpret diverse information
• Proven ability to manage priorities, set goals, and coordinate team activities
• Clear and concise written and verbal communication skills across all levels of an organization
• Deep understanding of quality engineering principles and medical device regulatory requirements, with the ability to train others