Software Safety Engineer

Here are the Job details for your review.

Job Role:
Sr Reliability Engineer/Senior Software Safety Engineer

Job Location:
8200 Coral Sea Street NE, Mounds View, Central Minnesota
55112

Job Duration: 12 Months (Contract)

The hiring manager is specifically looking for a candidate who can contribute approximately 30% to software development (including AI-driven process work) and 70% to risk management activities
.

There is a strong possibility for this contract role to convert into a full-time opportunity based on performance.

As a Senior Software Safety Engineer, you’ll play a critical role in designing and shaping cutting-edge cardiac rhythm management products that improve patient outcomes worldwide. 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.

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 cross-functional teams.
• 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.
• Design and develop reusable patterns and encourage innovation that will increase team velocity.

This position is in Mounds View, MN, within the Cardiac Rhythm Management (CRM) unit. 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 the successful completion of projects.

In general, the following responsibilities apply to 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 analyzes risk-benefit profiles for cardiac medical products.
• Completes risk analysis studies of new designs 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 and…