Senior Software Safety Engineer - CRM

Medtronic•Mounds View, MN

19h•$107,200 - $160,800•Remote

About The Position

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. As a Senior Software Safety Engineer at Medtronic, you’ll 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 teams—including product development, software reliability, cybersecurity, human research development, medical safety, and regulatory bodies—to 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. This position is fully remote 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 do. While we value in-person collaboration, this role is designed to support a remote-first work environment, leveraging virtual tools and intentional communication to foster strong cross-functional partnerships and professional growth. Occasional travel (less than 10%) may be required to support key meetings, strengthen team connections, and ensure successful project execution.

Requirements

Bachelor’s degree in Science, Technology, Engineering, Math or a related technical discipline and a minimum of 4 years of technical experience OR a Master's degree with a minimum of 2 years technical experience
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

Nice To Haves

Experience in a highly regulated industry, 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.
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
Previous clinical field experience, specifically with cardiac rhythm management products.
Medical doctor with related device experience
Engineer who has achieved IBHRE or NASPE Exam certification
Personnel with at least 5 years of clinical field experience in the past 15 years.
The relevant field experience could include the following: Nurse Field Personnel such as: Clinical Specialist, Technical Field Educator, Field Clinical Engineer Technical Services (cardiac products)
Personnel with at least 5 years of previous clinical experience related to cardiac therapy products.

Responsibilities

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.
Leverages relevant field experience and/or clinical knowledge 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.
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.

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)