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Senior Systems Risk Management Engineer

Careers That Change Lives 

At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. 

In this exciting role as a Senior Systems Risk Management Engineer supporting the Cardiac Ablation Solutions organization, you will have responsibility for supporting products in the post-commercialization phase of the product lifecycle. The scope of work includes assessment and determination of performance impact and risk associated with product nonconformances and trends, determination of actions to address nonconformances and potential increases in product risk, regulatory product performance and safety reports, and risk management file maintenance.

The Cardiac Ablations Solutions Unit develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

This position is in Mounds View, MN within the Cardiac Ablation Solutions Operating Unit and requires 3 days on-site per week. 

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life 

In general, the following responsibilities apply for the Senior Systems Risk Management Engineer role. This includes, but is not limited to the following:

  • Analyze and assess the system impact of process and product nonconformances.
  • Collaborate with technical subject matter experts to execute product risk assessments related to product nonconformances and performance trends associated with product released to the field.
  • Make decisions and recommendations on required actions associated with product issues (e.g. product hold order, health hazard assessment, and field corrective action).
  • Design quality management system processes which interface with other related processes.
  • Coach other engineers in the application of systems engineering principles and identify opportunities for applying systems engineering within work assigned to the team.
  • Own and author Period Safety Update Reports (PSURs).
  • Complete assessments to determine reportability for corrections and removals.
  • Make recommendations on risk management file updates and collaborate with the risk file owner on the execution of the updates.
  • May participate in CAPA activities including ownership of CAPA tasks.
  • Execute field corrective action (FCA) activities.
  • As necessary, propose changes to improve systems and/or processes.

Must Have - Minimum Requirements

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

  • Bachelor’s degree in engineering, math, statistics, or a technical discipline.
  • Minimum of 4+ years of work experience, or advanced degree with 2 years of experience.

Nice to Have

  • Advanced degree in System Engineering.
  • Medical device industry experience.
  • Experience in Systems Engineering, Quality Engineering, or execution of risk assessments for product released to the field.
  • Basic understanding of systems architecture and design controls.
  • Experience with risk management for medical devices and ISO 14971.
  • Familiarity with these regulations: FDA 21 CFR Part 820, EU 217/745 (EU MDR).
  • Familiarity with these standards: ISO 13485, ISO 14971, IEC 60601.
  • Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
  • Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team.
  • Experience owning or authoring risk analyses.

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

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) 

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here. 

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.  

Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience. 

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