Principal Design Assurance Engineer

Medtronic•Mounds View, MN

6d•$132,000 - $198,000•Onsite

About The Position

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.

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
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.
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 (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.

Nice To Haves

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

Responsibilities

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

Benefits

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)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)