We anticipate the application window for this opening will close on - 19 Jan 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Principal 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 Principal 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 increase in product risk, authoring 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 Principal Systems Risk Management Engineer role. This includes, but is not limited to the following:

• Analyze and determine the system impact of process and product nonconformances.
• Lead cross-functional teams in the creation of risk assessment strategy, including arguments and supporting evidence.
• 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).
• Determine 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.
• Propose and implement changes to improve systems and/or processes.

Qualifications

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 technology
• Minimum of 7+ years of technical work experience, or advanced degree with 5 years of experience.

Nice to Have

• Advanced degree in Systems Engineering.
• Proficient understanding of systems architecture and design controls.
• Experience in Systems Engineering, Quality Engineering, or execution of risk assessments for product released to the field.
• Experience in product development.
• Experience owning and authoring risk analyses and assessments.
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
• Medical device industry experience.
• Experience with the application of Design Controls for medical devices.
• Familiarity with these regulations: FDA 21 CFR Part 820, EU 217/745 (EU MDR)
• Familiarity with these standards:  ISO 13485, ISO 14971, IEC 60601.
• Experience with risk management for medical devices and ISO 14971.
• Demonstrated ability to act as a leader and mentor more junior engineers.
• Demonstrated ability to create strategies and influence cross-functionally

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,