Senior Design Assurance Engineer

AVE Medtronic Vascular Inc; Mounds View (MN); On-site; USD 107,000 - 161,000; Full time

Benefits offered by this job

Health, Dental and vision insurance

Health Savings Account

Tuition assistance/reimbursement

401(k) plan with employer match

Job summary

Medtronic is seeking a Senior Design Assurance Engineer for the Interventional Cardiology Therapy (ICT) team to lead design assurance across the product lifecycle. This role emphasizes robust design verification, risk management, and regulatory compliance to support regulatory approval and market launch.

The position requires on-site presence a minimum of 4 days per week and limited travel, with collaboration across cross-functional teams to deliver robust medical devices.

Qualifications

• Requires a degree and 4+ years of relevant experience, or Master's with 2+ years relevant experience, or PhD with 0 years relevant experience.
• Experience with FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 14971:2019
• Strong knowledge of design verification, validation, risk management, and regulatory compliance.

Responsibilities

• 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 activities to meet timelines
• Communicate progress to project leadership, presenting complex issues clearly
• Perform reliability analyses across requirements, architecture, interfaces, and design
• Lead risk management activities to ensure FDA/ISO compliance
• Lead and complete complex test method validation activities for system and capital equipment
• Drive continuous improvement in Design Assurance
• Identify, elevate, and resolve reliability and technical risks early
• Maintain up-to-date knowledge of regulatory compliance requirements
• Coordinate with test labs to complete design verification on time

Skills

Design Assurance

Regulatory compliance

Risk management

Reliability analysis

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

PhD

Tools

FTA

gage R&R

ANOVA

Reliability forecasting

Job description

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

• 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, elevate, 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.

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.

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):$107,200.00 - $160,800.00 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).

• 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
• Simple Steps (global well‑being program)

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.

Equal Employment Opportunity

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.

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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes.

Our industry leadership comes from the passion and ingenuity of our people.

That’s who we are.

Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life‑changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need.

Life‑transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care. Fresh viewpoints. Cutting‑edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care.

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.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.