Senior Design Assurance Engineer

Medtronic•Mounds View, MN

8d•Onsite

About The Position

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.

Requirements

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.
U.S. work authorization at the time of hire and for the duration of employment (unless the role is Principal-level or above, which may offer sponsorship).

Nice To Haves

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

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, 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.

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)