Sr. Reliability Engineer - Hardware / Electrical
About The Position
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.
Requirements
- 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
Nice To Haves
- 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 21CFR820, ISO13485, and ISO14971
- Medical Device Experience
- Electrical / Electronic Experience
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
Benefits
- 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
- Simple Steps (global well-being program)
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
