Senior Design Assurance Engineer

We anticipate the application window for this opening will close on - 9 Oct 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.A Day in the LifeMedtronic’s Interventional Cardiology Therapy (ICT) team is seeking a Senior Design Assurance Engineer to support the development of energy-based medical devices used to treat hypertension. Our mission is to provide technical leadership in Design Assurance throughout the product development lifecycle, partnering with cross-functional teams to develop robust, safe, and reliable medical devices. We lead the Design Verification strategy and execution, ensuring designs meet user and product requirements through rigorous design controls, effective risk management, and objective evidence that supports successful regulatory approval and market launch. This position requires on-site presence a minimum of 4 days per week. Regular in-person collaboration with cross-functional teams is an important part of supporting product development, decision-making, and project execution. This role also requires less than 10% travel to support business needs and project objectives.Responsibilities may include the following and other duties may be assigned:Serve as the Design Assurance representative on PDP projects, with dotted-line reporting to the Quality Core Team MemberCollaborate across a matrixed team to align priorities, solve problems, and achieve project goalsPlan and schedule your own activities, which are necessary to meet timelinesCommunicate progress to project leadership regularly, presenting complex issues in a clear, concise, and actionable wayPerform reliability analyses across requirements, architecture, interfaces, and design using tools such as FTA, failure trending, and reliability forecasting to assess product and process robustnessLead risk management activities to ensure compliance with FDA, ISO 14971:2019, and ISO 13485:2016 requirementsLead and complete complex test method validation activities for system and capital equipment test methods, including operator training, validation study design and sample size definition, data analysis (including crossed gage R&R, ANOVA, and probability of misclassification), reduction of variation sources, and report writingDrive continuous improvement in Design Assurance to boost efficiency, effectiveness, and complianceIdentify, escalate, and resolve reliability and technical risks early, ensuring appropriate mitigation and decision-making As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activitiesWork through extended team members and partner with test labs to facilitate timely completion of design verification activities in alignment with the overall project phase and project target milestones.Preferred QualificationsProject management experienceMedical Device Industry experienceFamiliarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 14971:2019 Experience in the management of complex data sets and statistical data analysisAbility to manage project timelines to execute deliverables in a timely mannerExperience in engineering development with extensive engineering knowledge and skills in some or all of the following: test method development, design for six sigma principles, pre-clinical evaluations, system requirements development, application of ISO standards for medical devices, capital equipmentRequired Qualifications:Requires a Baccalaureate degree AND minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experienceFor 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 RequirementsThe 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. ‌Recruitment Fraud AlertWe 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 View email address on click.appcast.io. ‌Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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):$107,200.00 - $160,800.00This 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 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.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.SummaryLocation: Mounds View, Minnesota, United States of AmericaType: Full time