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, 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)

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
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.
 

Salary ranges for U.S (excl. PR) locations (USD):$128,000.00 - $192,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

 

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

 

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

 

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.