Design Assurance Engineer

We are seeking a skilled Design Assurance Engineer to lead design assurance activities and support product development through design verification and validation. This role will involve developing and executing risk management and design control documents, driving the creation of test protocols, and ensuring compliance with regulatory standards. Responsibilities Lead design assurance activities and support product development through design verification and validation. Develop and execute risk management and design control documents, including DHF, DMR, and technical files. Drive the creation of test protocols and reports, ensuring compliance with regulatory and industry standards. Analyze testing data and prepare technical documentation for submissions to regulatory bodies. Oversee design reviews and provide constructive feedback to team members. Stay updated on industry trends and regulatory changes to enhance design assurance processes. Essential Skills 5+ years of experience in design assurance within the medical device industry. In-depth understanding of design control and risk management principles. Proven experience with FDA, ISO, and IEC regulations and standards. Proficient in statistical analysis software and methodologies. Strong communication skills and ability to work collaboratively in cross-functional teams. Demonstrated problem-solving abilities and attention to detail. Additional Skills & Qualifications Bachelor’s Degree in Engineering or a related field. Pay And Benefits The pay range for this position is $115,000.00 - $125,000.00/yr. Employer subsidized health insurance for employees Employer paid dental insurance Employer HSA contribution 401k plan with a company match 9 paid holidays (including your birthday!) + PTO and Personal days Gym membership subsidy Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance Workplace Type This is a fully onsite position in Maple Grove, MN. Application Deadline This position is anticipated to close on Oct 17, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. Actalent is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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