Principal Design Assurance Engineer

Overview

Medtronic’s Interventional Cardiology Therapy (ICT) Operating unit seeks a Principal Design Assurance Engineer to lead Design Assurance across the product lifecycle for energy‑based therapeutic medical devices treating hypertension.

• Lead Design Assurance activities across the full product cycle in alignment with project phases and milestones.
• Own design verification activities, ensuring test strategy and plans align with design inputs.
• Liaise with R&D and act as 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 per 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 and lead or support project investigations as needed.
• Quality lead for mechanical design support, including supporting design updates and mechanical design reviews.
• Identify, elevate, 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 activities.
• Work with extended team members and partner test labs to facilitate timely completion of design verification activities in alignment with the overall project phase and milestones.
• Distill complex issues into concise messages and work independently to plan and schedule activities necessary to meet timelines.

• Experience in engineering development with knowledge in testing method development, design for Six Sigma principles, pre‑clinical evaluations, system requirements development, and ISO standards for medical devices.
• 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 and ability to manage project timelines.

• Bachelor’s degree in science, technology, engineering, math or related field with a minimum of 7 years of technical experience, or an advanced degree with a minimum of 5 years of technical experience.
• Strong understanding of design control principles.
• For Baccalaureate degrees earned outside the United States, a degree that satisfies 8C.F.R. §214.2(h)(4)(iii)(A) is required.

Employees in this role should be independently mobile, interact with a computer, and communicate with peers and co‑workers. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

Base salary range (U.S. excl. Puerto Rico): $132,000–$198,000 per year. Short‑term incentive plan (MIP) may also apply. Benefits include health, dental, vision insurance, HSA, FSA, life insurance, long‑term disability, dependent daycare spending account, tuition assistance, 401(k) with employer match, paid time off, paid holidays, employee stock purchase plan, and global well‑being program. Additional benefits and compensation details are available to eligible employees.

Medtronic is an equal opportunity employer. We do not discriminate based on age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, or other protected characteristics. We provide reasonable accommodations for qualified individuals with disabilities.