Sr Reliability Engineer - Exempt

Senior Software Safety Engineer 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 Client 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 successful completion of projects. In general, the following responsibilities apply for 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 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 and develops 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 - 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 and minimum of 4+ years of work experience in engineering and/or quality OR advanced degree in engineering, science or technical field with 2+ 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.
• 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.
• Experience in design, maintenance, or continuation engineering of released software or software systems, including mobile applications.
• Working knowledge of artificial intelligence (AI) tools.
• 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.
• Proficiency in two or more of the following technologies: C++, Java, JavaScript, HTML, C#, .NET, Python, Angular, Xamarin.