Sr. Reliability Engineer - Hardware​/Electrical

Senior Reliability Engineer

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.

This is an exciting opportunity to support the continued scaling and improvement of Affera HW system in the Cardiac Ablation Solutions (CAS) Operating Unit as a Senior Reliability Engineer. The Affera system is a primary portfolio driver for the CAS OU with integrated mapping, navigation, RF, and PF ablation functionality. This Reliability role is on the Affera HW REL team with full lifecycle scope and a focus on released product engineering, next generation ablation generator development, and quality response.

The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team.

About the Affera Mapping and Ablation System The Affera Mapping and Ablation System is an innovative medical technology designed to treat patients with cardiac arrhythmias. The system involves advanced mapping techniques to create detailed images of the heart's electrical activity, helping physicians identify abnormal areas causing arrhythmias. Once identified, the Affera Ablation System delivers targeted energy to disrupt these abnormal signals, restoring normal heart rhythm.

• Develops, coordinates and conducts technical reliability 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.
• 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 engineering programs to achieve company, customer and governmental agency reliability objectives.
• May develop mathematical models to identify units, batches or processes posing excessive failure risks.
• As necessary, proposes changes in design or formulation to improve system and/or process reliability.
• May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
• Additional product Reliability responsibilities may be included, primarily focused on Affera Capital (HW) equipment DRM, change management, risk management, and risk response

• Bachelor's degree and a minimum of 4 years of relevant experience
• OR Master's degree with a minimum of 2 years of relevant experience
• OR PhD with 0 years relevant experience

• Thorough understanding and experience in design controls, V&V, and Risk Management - both commercial and development.
• System-thinking and process mapping, ability to effectively identify interfaces, dependencies, and control points.
• Demonstrated ability in stakeholder management and coordinating complex assignments with cross-functional teams
• Understanding of 21
  
  CFR
  820, ISO
  13485, and ISO
  14971
• Medical Device Experience
• Electrical / Electronic Experience

Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.

We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$ - $This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:
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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:
Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays,…