Key Responsibilities:

Develop and maintain comprehensive strategies for risk management activities, including: Collaborating cross-functionally to ensure the utmost product quality for patient safety Creating 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 lifecycle Developing 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 tool Evaluate the safety risk implications of design changes Other potential responsibilities: 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. Oversee design validation and design verification activities of user needs and design inputs, including the development of test plans, protocols, test methods and reports. Ensure thorough and accurate documentation including test results, risk assessments, and reports.

Minimum Requirements:

Bachelors degree in engineering or a related technical field

Preferred Qualifications:

Experience in medical devices , pharmaceuticals, or combination products Familiarity with medical device risk management standards (e.g., ISO 14971 concepts) Prior involvement in New Product Development (NPD) environments Background in Quality Engineering, Risk Management, R D, Systems Engineering, or similar roles Clinical knowledge or experience supporting clinical risk assessment Experience using Minitab or other statistical analysis software Certification or experience with Design for Six Sigma / Design for Reliability methodologies Strong written, verbal, and digital communication skills Proficiency with Microsoft Office tools (Excel, Word, PowerPoint)

Certifications:

Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

For Office Roles:

While performing the duties of this job, the employee is regularly required to be independently mobile. 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. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.\n‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 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. Any such requests are not legitimate. 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 .\n‌ Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$66,400.00 - $99,600.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. 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). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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). The following benefits and additional compensation are available to all regular employees: 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). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans It 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. If you are applying to perform work for Medtronic, Inc. 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Risk Management Quality Engineer I - New Product Development (Surgical)