Jobs in United States

We anticipate the application window for this opening will close on - 31 Oct 2025

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

Responsibility for providing risk management expertise and best practices for released products and post-market activities within the Advanced Surgical Technologies organization. This includes evaluating product issues to ensure patient, user and security risk are assessed, and acting as the Quality Engineer Risk Management file owner for the CSI capital hardware and disposable products.

Responsibilities may include the following and other duties may be assigned.

• Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families
• Accountable for and owns the Risk Management Files for assigned product families
• Maintains Risk Management Files for assigned product families
• Conducts product Risk Analysis (PHA, RAC, SSRCI/System & Use FMEAs) in compliance with ISO14971
• Evaluates product Risk Management Files against field data to ensure accuracy and correctness of predicted risks; validating pre-market Benefit Risk Analysis and updating the Risk Management Files (RMF) as necessitated
• Initiates and manages Product Hold Orders (PHOs) based upon production and field issues, working with cross-functional teams to develop comprehensive and evidence-based disposition plans
• Initiates and drives Post-Market Issue Evaluations (PMIE) and Health Risk Assessments (HRA) to closure based upon production and field issues, taking into consideration inputs from cross-functional teams
• Initiates and serves as owner/lead for Field Corrective Actions (FCAs) based upon HRA decision working alongside Enterprise FCA team
• Supports post-market regulatory body and competent authority engagements, including but not exclusive to: Post-Market Surveillance Report (PMSR), Periodic Safety Update Report (PSUR), Clinical Evaluation Report (CER), Summary of Safety and Clinical Performance (SSCP), Clinical Evaluation Plan (CEP), and Requests For Additional Information (RFAI)
• Reviews and endorses Production Post-Production Risk Assessments (PPPRAs) for Change Development Projects (CDPs), as Risk Management SME
• Consults on New Product Development programs during the Product Transfer to ensure Risk Management Files readiness for post-market. Including review of Risk Management Report (RMR) and Post-Market Surveillance Plan (PMSP).
• Supports and collaborates with Post-Market Vigilance team to investigate complaints into potential adverse trends and aids in the early signal detection of field issues

• Requires a Bachelor’s degree in an engineering, math or science discipline
• For degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)
• Minimum of 6 years of combined experience in quality, engineering or a related function, or an advanced degree with a minimum of 4 years of combined experience in quality, engineering or a related function

• Risk Management experience in the medical device industry
• Risk Management File lifecycle accountability
• Statistical analysis tools and techniques
• Significant breadth and depth in quality decision making, risk management, quality engineering, reliability engineering, and writing for compliance.
• Knowledge and expertise in FDA 21 CFR 820 & 806, EU MDR (Regulation (EU) 2017/745), ISO 14971, ISO 24971, IEC 60812, and ISO 13485

• Experience in engaging with Regulatory Agencies and customers / clinicians
• DRM or Six Sigma Certification
• Experience with complex capital equipment or disposable medical devices or medical device software
• Reliability Engineering test experience
• Typically has deep domain expertise and applies extensive engineering and industry expertise
• Knowledge of IEC 62366-1, IEC 60601-1, IEC 62304, IEC 82304, BS/AAMI 34971

• Occasional visits to product manufacturing and design centers, as well as potential visits to Regulatory Bodies as needed.

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.

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): $96,800.00 - $145,200.00. 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. Some benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

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. ("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. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.