Senior Reliability Engineer
Medtronic
Summary
Medtronic has a Senior Reliability Engineer role within their Intervention Cardiology Therapy (ICT) Operating unit focusing on Renal Denervation (RDN) where you will be an integral part of the Design Assurance team. Our purpose is to increase product development process rigor to ensure robust understanding of designs, documentation of compliance to requirements and timely, high-quality product launches that satisfy patient needs.
Job description
This role will leverage both technical breadth and business acumen and participate in the design and development of next generation medical devices. This position will be based at our Mounds View, MN facility which requires a minimum of 4 days per week on-site for in-person collaboration. This role may require up to 10% travel to support business objectives, in-person meetings and project activities.
Primary Responsibilities
- Support defining and allocating reliability requirements and goals
- Execute reliability demonstration strategies, reliability growth activities, and recommend design and manufacturing updates to ensure design achieves required levels of product reliability
- Develop test plans, determine statistically valid sample sizes, work with test labs to demonstrate performance, address test observations, statistically analyze data, and write test reports
- Perform reliability testing as defined by development project plans and product requirements
- Participate in defining product reliability requirements, product use cases, and develop associated test methods
- Assist Research and Development (R&D) engineers with new product development and design for reliability across systems (mechanical, electrical, and software)
- Contribute to planning, design, development, and evaluation of the company's products including its subassemblies, components, and packaging through effective feedback of reliability test results
- Contribute to the review of supplier capability to support reliability characterization
- Support Design Assurance activities e.g. risk, design verification, test development, compliance
- Apply knowledge of design control principles and quality engineering techniques throughout the product development process
- Contribute to the product development team and be responsible for supporting activities required to ensure development and validation of new product introduction
- Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements
Required Qualifications
- Baccalaureate degree in Engineering, Math, Science, or a technical discipline AND 4+ years of relevant experience, OR Master's degree with 2+ years relevant experience, OR PhD with 0 years relevant experience
Preferred Qualifications
- Medical device industry experience
- Experience in reliability testing of electromechanical devices controlled by embedded software
- Experience in deploying tools that measure reliability performance at the component, device, or system level, including designing, building, programming, debugging, documenting, training, and releasing such tooling
- Experience with generating reliability metrics and summaries including Warranty Predictions (Parts Count and Reliability Block Diagram), Unreliability and Nevada charts, and Time to Failure using ReliaSoft, JMP, Minitab or equivalent software
- Experience creating and releasing test protocols, compiling test results, and compiling and releasing the related test reports
- Experience with Accelerated Life Testing, Risk Analysis, DFMEA, Reliability Growth, and/or Demonstration Testing
- ASQ CRE Certified
- 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
Requirements
- Baccalaureate degree in Engineering, Math, Science, or a technical discipline AND 4+ years of relevant experience, OR Master's degree with 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
- Unrestricted U.S. work authorization required (roles below Principal level)
Benefits
- Health, Dental & Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- 401(k) Matching
- Short-term Disability
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Incentive Plans
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.