Design Assurance Engineer - 246299

Design Assurance Engineer (Direct Hire) Location: Maple Grove, MNPay: $100K - $120K annually, based on experienceQualifications:Bachelor's degree in Engineering or a related discipline (Master's 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: Lead design assurance activities for new and existing product development projects, including design verification and validation efforts.Develop and maintain design control and risk management documentation, such as DHF, DMR, and technical files.Create and oversee test protocols and reports to ensure alignment with FDA, ISO, and IEC standards.Analyze test results and prepare high-quality technical documentation for regulatory submissions.Facilitate design reviews and provide strategic input to enhance product quality and safety.Monitor evolving regulatory requirements and industry trends to drive continuous improvement in design assurance practices.

Created: 2025-10-05