Senior Software Safety Engineer

Role Description

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.

In this exciting role, you’ll:

• 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 Medtronic’s mission to transform lives.

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.

Qualifications

• 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.
• 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.
• 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 Life 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.

Requirements

• One or more of the following qualifications:
• 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, including roles such as Nurse, Clinical Specialist, Technical Field Educator, Field Clinical Engineer, or Technical Services (cardiac products).
• Personnel with at least 5 years of previous clinical experience related to cardiac therapy products.

Benefits

• Competitive Salary and flexible Benefits Package.
• 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.
• 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).