Sr. Reliability Engineer - Hardware​/Electrical

Senior Reliability Engineer

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

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.

Primary Responsibilities

• 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

Required Qualifications

• 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

Preferred Qualifications

• 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

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles:
While performing the duties of…