Senior Software Safety Engineer CRM

Medtronic

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profile Job Location:

Mounds View, MN - USA

profile Monthly Salary: $ 106400 - 159600
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

We anticipate the application window for this opening will close on - 23 Oct 2025


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

A Day in the Life

Senior Software Safety 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.

The Cardiac Rhythm Management (CRM) Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. We are comprised of three businesses:

Cardiac Pacing Therapies
Cardiovascular Diagnostics & Services
Defibrillation Solutions

We put people first in all we do as we remain on the leading edge of innovation to ensure that we treat more people year after year. We excel in how we operate to deliver the best experiences for people who touch our therapies.

Join Our Mission to Revolutionize Patient Safety as a Senior Software Safety Engineer! In this exciting role as a Senior Software Safety Engineer you will have responsibility for ensuring our software products exceed the safety and reliability requirements and expectations of patients clinicians regulators and the business.

Are you ready to make a meaningful impact on lives while working at the forefront of medical innovation As a Senior Software Safety Engineer at Medtronic youll play a critical role in designing and shaping cutting-edge cardiac rhythm management products that improve patient outcomes worldwide.

This is your chance to collaborate with diverse cross-functional teamsincluding product development software reliability cybersecurity human research development medical safety and regulatory bodiesto ensure our products meet the highest safety and performance standards. Your expertise will directly influence the development production and market release of life-saving technologies.

In this exciting role youll:

Identify and mitigate patient safety hazards within Medtronic software working closely with medical safety teams to evaluate device safety from a clinical perspective.

Ensure risk management files are meticulously developed and maintained in compliance with ISO 13485 ISO 14971 and IEC 62304 standards while providing critical feedback during the design input and output phases.

Lead efforts to trace design validation and verification in risk management files ensuring every safety measure aligns with global standards.

Recommend innovative risk mitigations and deliver data-driven risk-versus-benefit analyses to project stakeholders always keeping patient safety as the top priority.

If you thrive in a fast-paced collaborative environment and are passionate about advancing healthcare through technology this is the perfect opportunity for you to make a lasting impact. Join us in shaping the future of cardiac rhythm management and become a key driver in Medtronics mission to transform lives.

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.

This position is in Mounds View MN. within the Cardiac Rhythm Management (CRM) Operating Unit. At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. We are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

A Day in the Life

In general the following responsibilities apply for the Senior Software Safety Engineer role. This includes but is not limited to the following:

  • Collaborates with cross-functional teams to develop and release new cardiac rhythm management software products and design changes.

  • Completes risk severity and occurrence determination and analyze risk benefit profiles for cardiac medical products.

  • 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/safety engineering programs to achieve company customer and governmental agency reliability/safety objectives.

  • Develops coordinates and conducts technical reliability/safety 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 and safety.

  • Proposes changes in design or formulation to improve system and/or process reliability and product safety.

Qualifications

Must Have - Minimum Requirements

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

  • Bachelors degree in Science Technology Engineering Math or a related technical discipline and a minimum of 4 years of technical experience OR a Masters degree with a minimum of 2 years technical experience

Nice to Have

  • Experience in ahighly regulatedindustry preferably implantable medical devices
  • Advanced degree in Engineering or suitable Clinical/Field Support Safety or Reliability Engineering Biomedical Engineering software development / test or Product Development Engineering experience
  • Experience with 21 CFR Part 820 (Quality System Regulation) ISO 13485 ISO 14971 and Hazard Analysis and Risk Analysis techniques (e.g. FTA DFMEA Hazard Analysis Logs Risk Management Report & Files) IEC 62304 / 82304.
  • Strong written and verbal communication skills and ability to work cooperatively and influence outcomes as part of a cross-functional team
  • Ability to manage project timelines to execute tasks and deliverables in a timely manner
  • Experience in the design maintenance or continuation engineering of released software or software systems including mobile applications
  • Knowledge of Software Development Live Cycle (SDLC) Design for Reliability (DfR) Design for Reliability and Manufacturability (DRM) Design for Six Sigma (DFSS) Design for Lean Sigma (DFLS) and/or robust design practices

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. Lets 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 accommodation 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):$106400.00 - $159600.00

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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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 95000 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.


Required Experience:

Senior IC

We anticipate the application window for this opening will close on - 23 Oct 2025At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected c...
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Key Skills

  • Databases
  • Embedded Software
  • IDS
  • System Design
  • C/C++
  • Military Experience
  • Risk Analysis
  • Systems Engineering
  • Waterfall
  • Requirements Management
  • OSHA
  • EHS

About Company

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About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 excit ... View more

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