Design Assurance Engineer - 246299 (Minneapolis)

Design Assurance Engineer (Direct Hire)

Location : Maple Grove, MN

Pay : $100K - $120K annually, based on experience

Qualifications :

• Bachelors degree in Engineering or a related discipline (Masters degree preferred).
• Minimum of 5 years of experience in design assurance within the medical device industry.
• Deep understanding of design controls and risk management principles under FDA and ISO guidelines.
• Demonstrated experience with regulatory frameworks, including FDA 21 CFR 820, ISO 13485, and IEC 60601 or similar standards.
• Proficient in statistical tools and software used for data analysis.
• Strong communication skills and a collaborative approach to cross-functional teamwork.
• Meticulous attention to detail and proven problem-solving capabilities.

Responsibilities :