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Pre-Market Software Safety Engineer Level II - CRM
Pre-Market Software Safety Engineer Level II - CRMMedtronic • Mounds View, MN, US
Pre-Market Software Safety Engineer Level II - CRM

Pre-Market Software Safety Engineer Level II - CRM

Medtronic • Mounds View, MN, US
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We anticipate the application window for this opening will close on - 10 Oct 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

Pre-Market Software Safety Engineer II

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.

Cardiac Rhythm Management (CRM) Integrated 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 prioritize people in everything we do, remaining at the forefront of innovation to treat more patients. Our commitment to operational excellence ensures we deliver exceptional experiences for those impacted by our therapies.

In this exciting role as a Pre-Market Software Safety Engineer II, you will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.

This position offers an exciting opportunity to drive software reliability and safety engineering within dynamic new product development teams for R&D. The candidate will be a pivotal member of cross-functional teams, serving as the go-to expert for reliability, safety, and quality functions.

As a core member of the R&D project teams, the Pre-Market Software Safety Engineer II will drive excellence in quality and reliability programs. This dynamic role involves leading Design for Reliability (DfR) initiatives, offering technical expertise, actively participating in design and risk reviews, and shaping the development of cutting-edge technologies. Collaborating with multidisciplinary teams, the position is pivotal in ensuring that innovative solutions meet the highest safety and reliability standards, fostering impactful advancements in patient care.

This position is in Mounds View, MN, within the Cardiac Rhythm Management (CRM) unit. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-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% travel to enhance collaboration and ensure successful completion of projects.

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.

Responsibilities

In general, the following responsibilities apply for the Pre-Market Software Safety Engineer II role. This includes, but is not limited to the following :

  • Leverage relevant medical technology experience to ensure the practical applicability and safety of our products in real-world settings.
  • Completes risk severity and occurrence determination and analyze risk benefit profiles for cardiac medical products.
  • Completes risk analysis studies of new design and processes.
  • Ensures that corrective measures meet acceptable reliability / safety standards.
  • Analyzes preliminary plans and develops reliability / safety engineering programs to achieve company, customer and governmental agency reliability / safety objectives.
  • Support 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

  • Bachelor's degree in engineering, math, science or technical discipline
  • Minimum of 2 years of work experience in engineering and / or quality OR advanced degree in engineering, science or technical field with years of work experience in engineering and / or quality.
  • Nice to Have

  • Advanced degree in engineering or science.
  • Proven understanding of product reliability / safety engineering principles.
  • Strong understanding of and experience in the application of statistics.
  • Experience in a highly regulated industry, preferably implantable medical devices.
  • Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
  • Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA).
  • Certified Software Reliability Engineer (CSRE) certified.
  • Exposure to or experience working in or with design, quality, regulatory, clinical and / or manufacturing.
  • Experience in design, maintenance, or continuation engineering of released software or software systems, including mobile applications.
  • Knowledge of 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.
  • Previous clinical field experience, specifically with cardiac rhythm management products.
  • 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 95,000+ 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.

    EEO and Compliance

    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. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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