Principal Design Assurance Engineer

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.

About the role

Medtronic’s Interventional Cardiology Therapy (ICT) Operating unit is looking for a Principal Design Assurance Engineer to be part of a high-performing team that is revolutionizing the design and development of energy-based therapeutic medical devices to treat hypertension. In this role, you'll be a key member of the Premarket Design Assurance team, providing technical leadership in Design Assurance throughout the product development lifecycle. You will partner with cross-functional teams to develop robust, safe, and reliable medical devices, leading the Design Verification strategy and execution to ensure designs meet user and product requirements through rigorous design controls, effective risk management, and objective evidence that supports successful regulatory approval and market launch.

Join a diverse team of innovators who bring their worldview, unique backgrounds, and individual life experiences to work every day. This role is primarily onsite, with a minimum of 4 days per week in the office to foster professional growth and cross-functional collaboration. Travel requirements are less than 10% to enhance collaboration and ensure project success.

Responsibilities

• Lead Design Assurance activities across the full product lifecycle in alignment with project phases and target milestones.
• Own design verification activities, ensuring test strategy and plans align with design inputs.
• Liaise with R&D and act as the design assurance subject matter expert for design validation and human factors strategies.
• Support design requirements flow down from user needs to design requirements, outputs, and test methods.
• Partner with cross-functional teams to ensure traceability between design requirements, risk management, and design verification test strategy.
• Contribute to risk management activities, including DFMEA/FMECA development, hazard analysis, and risk file updates aligned to ISO 14971.
• Build strong partnerships across Systems, Software, Hardware, Mechanical Engineering, Clinical, Regulatory Affairs, and Manufacturing to deliver complex technical milestones.
• Exhibit strong problem-solving skills, lead and support project investigations as needed.
• Serve as the quality lead for mechanical design support, including design updates and reviews.
• Identify, escalate, and resolve reliability and technical risks early, ensuring appropriate mitigation and decision-making.
• Maintain up-to-date knowledge of regulatory compliance requirements for product design, development, transfer, and commercialization.
• Work through extended team members and partner with test labs to facilitate timely completion of design verification activities.
• Distill complex issues into concise and clear messages.
• Work independently to plan and schedule activities necessary to meet timelines.

Requirements

• Bachelor's degree in science, technology, engineering, math, or a related technical field with a minimum of 7 years of technical experience, OR an advanced degree in a related field with a minimum of 5 years of technical experience.
• Strong understanding of design control principles.
• 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.

Preferred Qualifications

• Experience in engineering development with extensive knowledge and skills in test method development, design for six sigma principles, pre-clinical evaluations, system requirements development, application of ISO standards for medical devices, or capital equipment.
• Medical Device Industry experience.
• Familiarity with FDA 21 CFR Part 820 cGMP, ISO 13485, and ISO 14971:2019.
• Experience in management of complex data sets and statistical data analysis.
• Practical knowledge of project management.
• Ability to manage project timelines to execute deliverables in a timely manner.

Benefits

The following benefits and additional compensation are available to regular employees who work 20+ hours per week:

• Health, dental, and vision insurance.
• Health Savings Account and Healthcare Flexible Spending Account.
• Life insurance and long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance/reimbursement.
• Simple Steps (global well-being program).
• Incentive plans, including the Medtronic Incentive Plan (MIP).
• 401(k) plan plus employer contribution and match.
• Paid time off and paid holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums).
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Note: Some benefits may not apply to workers in Puerto Rico. Temporary employees are eligible for paid sick time and the Employee Stock Purchase Plan.

Pay

Salary ranges for U.S. locations (excluding Puerto Rico) are $132,000.00 - $198,000.00 USD. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Schedule

This role requires onsite work a minimum of 4 days per week. Travel requirements are less than 10%.