Principal Design Assurance Engineer at AVE Medtronic Vascular Inc — Mounds View, MN

A Day in the Life

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 exciting role, you'll be a key member of the Premarket Design Assurance team. 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.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

What’s in it for you:

• Impact that matters: Contribute directly to the development of life-saving medical devices in a novel and innovative and growing market sector
• Leadership growth: Lead a skilled team and collaborate with world-class experts across multiple disciplines
• Innovation at scale: Shape the future of testing through automation, advanced validation techniques, and cutting-edge equipment
• Professional development: Stay at the forefront of regulatory and technical advancements while growing your expertise in a highly regulated, innovative industry
• A mission-driven culture: Join a team where your work not only challenges you technically but also makes a real difference in patients’ lives worldwide

• Lead Design Assurance activities across full product cycle in alignment with the overall project phase and project target milestones
• Own design verification activities, ensuring test strategy and plans aligned with design inputs
• Liaise with R&D and act as the design assurance SME for design validation and human factors strategies
• Support design requirements flow down from user needs to design requirements to 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
• Quality lead for any mechanical design support required including supporting design updates and mechanical design reviews
• 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
• Be able to distill complex issues into concise and clear messages
• Work independently to plan and schedule activities necessary to meet timelines

Nice to Have (Preferred Qualifications):

• 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
• Medical Device Industry experience
• Familiarity with these regulations: FDA 21 CFR Part 820 cGMP, ISO 13485, 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

Must Have (Minimum Requirements):

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

Physical Job Requirements

U.S. Work Authorization & Sponsorship

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Benefits & Compensation

Salary ranges for U.S (excl. PR) locations (USD):$132,000.00 - $198,000.00