<p>Elevate Your Career: Sustaining Systems Design Quality Engineer</p> <p>Are you ready to make an impact in the medical device industry? This is your chance to join a global leader in innovation, where your expertise in engineering and quality assurance directly supports life-saving medical technology. We are seeking a Sustaining Systems Design Quality Engineer to play a key role in ensuring the safety, reliability, and compliance of groundbreaking products within the Interventional Cardiology division.</p> <p>Hours & Pay</p> <p>Schedule: Monday - Friday, 8:00 AM - 4:30 PM</p> <p>Pay: Up to $44.00 per hour</p> <p>Work Model: Hybrid (3 days onsite, Maple Grove, MN)</p> <p>Employment Type: Full-time opportunity through Advantage Technical</p> <p>Why You'll Love This Role</p> <p>This position offers the unique opportunity to contribute to medical electrical equipment/systems (MEE) used in interventional cardiology-a rapidly expanding field. You'll collaborate with high-performing cross-functional teams, applying your skills in design quality engineering to support design changes, regulatory compliance, risk management, and improvements in manufacturability and cost efficiency. Plus, you'll enjoy a hybrid schedule (3 days onsite), competitive pay of up to $44/hour, and a comprehensive benefits package that supports both your professional and personal well-being.</p> <p>What You'll Do</p> <ul> <li>Take ownership of design change projects, including scoping, assessment, and implementation </li><li>Develop, update, and maintain Design History Files and Design Input/Output documentation </li><li>Update and manage risk management files, including Hazard Analysis, Task Analysis, and Design FMEA </li><li>Create and execute Design Verification, Validation, and Usability protocols and reports </li><li>Support resolution of PIRs, CAPAs, and NCEPs with design quality expertise </li><li>Apply systematic problem-solving methods to identify, prioritize, and resolve quality issues </li><li>Ensure compliance with internal processes, regulatory requirements, and industry standards </li><li>Maintain a strong commitment to patient safety and product quality in all aspects of your work </li></ul> <p>What We're Looking For</p> <ul> <li>Bachelor's degree in mechanical, electrical, or biomedical engineering (required and must be clearly stated on resume) </li><li>3-5 years of engineering experience in a related field </li><li>Experience with design control, risk management, and medical device standards compliance </li><li>Knowledge of corrective and preventive action processes </li><li>Excellent communication skills (written and verbal) </li><li>Ability to work both collaboratively in cross-functional teams and independently in self-directed projects </li></ul> <p>Benefits That Work for You</p> <p>We believe in taking care of our team members both inside and outside of work. As part of this opportunity, you'll enjoy:</p> <ul> <li>Medical, dental, and vision insurance </li><li>Pet insurance options </li><li>401(k) retirement savings plan </li><li>Employee Assistance Program (EAP) </li><li>Commuter and parking accounts </li><li>Health Savings Account (HSA) </li><li>Accidental Death & Dismemberment (AD&D) insurance </li><li>Exclusive employee discounts through "People Perks" </li><li>And more! </li></ul> <p>Apply Today</p> <p>If you're a skilled engineer passionate about medical device quality assurance and want to make a difference in patients' lives, this role is for you. Don't wait-click Apply Now to take the next step in your engineering career!</p> <p>The law requires employers with 30 or more employees at one or more sites in Minnesota to disclose in each job posting the starting salary range and a general description of all benefits and other compensation including health or retirement benefits, bonuses, or other financial benefits to be offered.</p> <p>After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.</p>