Senior Design Assurance Engineer
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.
- The employee is also required to interact with a computer, and communicate with peers and co-workers.
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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
