Quality Engineering Senior

We anticipate the application window for this opening will close on - 18 Sep 2026Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Senior Risk Management Quality Engineer to join our innovative team. This role will be in the surgical operating unit within the new product development quality team. The ideal candidate will have a strong background in risk management, product development, design controls and regulatory compliance within the medical device industry. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle.Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Senior Risk Management Quality Engineer to join our innovative team. This role will be in the surgical operating unit within the new product development quality team. The ideal candidate will have a strong background in risk management, product development, design controls and regulatory compliance within the medical device industry. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle.Develop and maintain comprehensive strategies for risk management activities, including:Collaborating cross-functionally to ensure the utmost product quality for patient safetyCreating and maintaining the risk management file, including the risk management plans and reports, as well as conducting regular risk reviews.Leading hazard and risk analysis activities to identify potential risks and implement effective risk control measures.Leading Design Failure Modes and Effects Analyses (DFMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts.Analyzing and reviewing product complaints to anticipate and prevent future issues.Integrating product security measures to protect against potential vulnerabilities into the risk management file.Participating in Process FMEA/User FMEA development and integrating the Process FMEA/User FMEA into the risk management file.Leading design review and maintaining the risk management file throughout the product lifecycleDeveloping and managing post-market surveillance plans to monitor product performance and safety in the field.Leading field issue evaluation (including root cause analysis, risk evaluation, product containment strategy) during initial launch.Ensuring traceability between risk management file, requirements and design outputs utilizing a requirements management toolEvaluate the safety risk implications of design changesOther potential responsibilitiesLead and mentor teams in the development, implementation, and maintenance of the quality system processes and standards.Collaborate with cross-functional teams, to define and implement engineering and statistical processes that ensure product quality and compliance throughout the product lifecycle.Ensure compliance with relevant regulatory requirements, including FDA, ISO (e.g., 14971, 13485, 62304, FDA Part 820), and other international standards, and participate in regulatory audits and inspections.Ensure thorough and accurate documentation including test results, risk assessments, and reports.Qualifications:Minimum Requirements:Education: Minimum bachelor’s degree in engineering, or a related technical field. Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.Preferred Qualifications:Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.Experience: Regulated engineering fieldIndustry Experience: Medical device industry.Proficient in quality management systems, risk management, regulatory compliance, and statistics.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA commitment to our employees lives at the core of our values. They share in the success they help to create. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Medtronic benefits and compensation plansIt is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. North Haven, Connecticut, United States of AmericaType: Full time