Principal Software Safety Engineer - CRM

Medtronic • Minneapolis, MN

1d • $132,000 - $198,000 • Onsite

About The Position

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 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. 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, And Defibrillation Solutions. We put people first in all we do. We remain on the leading edge of innovation to ensure that we treat more people. We excel in how we operate to deliver the best experiences for people who touch our therapies. In this exciting role as a Principal Software Safety Engineer, 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 Principal Software Safety Engineer 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% of 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.

Requirements

• Requires a Baccalaureate degree and minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.

Nice To Haves

• Proven understanding of product reliability/safety engineering principles.
• 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, HAL, FTA, DFMEA).
• Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
• Certified Software Reliability Engineer (CSRE) certified.
• Exposure to or experience working in or with design, quality, regulatory, clinical and/or manufacturing.
• Experience in the 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.

Responsibilities

• Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.
• Manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
• Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area.
• Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
• 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 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.

Benefits

• 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
• Simple Steps (global well-being program)
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal