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210009XW Requisition #

Careers that Change Lives

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. 

In this exciting role as a Sr Reliability Engineer you will have responsibility for supporting critical components in medical devices throughout the product lifecycle including during new product development, design transfer, production and in post-market surveillance.  This role will initially focus on capacitors, but other opportunities include ensuring reliable system level interaction with energy components and development and support of rechargeable batteries.

The Medtronic Energy and Component Center (MECC) develops new technologies related to critical medical device components, designs, develops and manufactures those components and provides support to post-market surveillance activities for fielded product.  MECC components are used in a wide variety of Medtronic Devices including pacemakers, implantable defibrillators, heart failure devices, drug pumps, deep brain stimulators and spinal cord and other nerve stimulators.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

  • Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
  • Drive risk management activities including component level risk analysis, DFMEA and Fault Tree Analysis.  Coordinate with quality engineers on PFMEA development and with reliability engineers at supported business units for system level risk analysis.
  • Review of all project / program work products (e.g. plans, requirements, specifications, tests, test results, traceability, design reviews, reports, etc.).
  • Participate in design reviews with a focus on component reliability.  Drive design risk reduction activities including proposing, developing, executing and reporting test activities supporting component reliability.
  • Drive component level design verification activities for new product development or in support of design changes in conjunction with R& D, Process Engineering, Manufacturing, Supplier Quality Assurance, Regulatory Affairs, Marketing and other service groups.
  • Assist Manufacturing with problem solving related to production issues with a focus on potential impact to component reliability.
  • Support analysis of returned products and root cause analysis for any identified failures.
  • Provide work direction to reliability technicians for specific projects in support of development, operations, and/or analysis of returned products.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.

Nice to Have

  • Experience in a medical device manufacturing environment.
  • Working knowledge of ISO 13485, ISO 14971, and 21 CFR 820.
  • Working experience with internationally certified quality systems, USFDA Quality System Regulation, or other mature regulatory or process models.
  • ASQ Certification in Quality or Reliability.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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