Senior Design Assurance Engineer

We anticipate the application window for this opening will close on - 9 Oct 2026 Careers 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 Life Medtronic’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 Member Collaborate across a matrixed team to align priorities, solve problems, and achieve project goals Plan and schedule your own activities, which are necessary to meet timelines Communicate progress to project leadership regularly, presenting complex issues in a clear, concise, and actionable way Perform reliability analyses across requirements, architecture, interfaces, and design using tools such as FTA, failure trending, and reliability forecasting to assess product and process robustness Lead risk management activities to ensure compliance with FDA, ISO 14971:2019, and ISO 13485:2016 requirements Lead 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 writing Drive continuous improvement in Design Assurance to boost efficiency, effectiveness, and compliance Identify, 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 activities Work 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 Qualifications Project management experience Medical Device Industry experience Familiarity 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 analysis Ability to manage project timelines to execute deliverables in a timely manner Experience 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 equipment Required 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 experience 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. ‌ 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