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Medtronic

Sr. Quality Engineer

Medtronic, Minneapolis, Minnesota, United States, 55400

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We anticipate the application window for this opening will close on

14 Oct 2025 . Position Description:

Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in Fridley, MN. Responsible for New Product Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. Ensure the development and maintenance of high-quality, reliable, and safe medical devices that meet or exceed regulatory standards and customer expectations. Coordinate complaint investigations for Medtronic’s returned implantable devices, including handling, cleaning, and sterilization processes. Manage test results, clinical data, Device History Records (DHR), and product performance data. Conduct complaint analysis, trending, and predictive analysis for new products. Responsibilities include risk management, updating quality-controlled documents, root cause analysis, process improvements using Lean Six Sigma techniques, validation activities, and investigations of non-conformances. The role involves working with combination products (pharmaceutical and medical devices) and leveraging knowledge as a Certified Quality Engineer (CQE) from ASQ. Basic Qualifications:

Master's Degree in Mechanical, Industrial, Chemical, Biomedical Engineering, or related field, with at least two years of experience in manufacturing or quality engineering. Must have at least two years’ experience handling returned implantable devices, sterilization processes, data analysis, and familiarity with ISO standards, FDA regulations, root cause analysis, Lean Six Sigma, statistical tools, CAPA, and working with combination products. ASQ CQE certification is required. The position is hybrid, based in Fridley, MN, working onsite 3-4 days per week. Salary:

$110,400 to $145,200 per year. Benefits:

Includes health, dental, vision insurance, HSA, FSA, life insurance, disability leave, tuition reimbursement, and well-being programs. Additional benefits include incentive plans, 401(k) with employer contributions, employee stock purchase, paid time off, holidays, employee assistance, and retirement plans. Some benefits may vary by location and employment status. Further details are available at the link below:

Medtronic benefits and compensation plans

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