Reliability Engineer II - Hardware / Electrical at MED Medtronic Inc — Mounds View, MN

A Day in the Life

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 Reliability Engineer. The Affera system is a primary portfolio driver for the CAS OU with integrated mapping, navigation, RF, and PF functionality. This Reliability role is on the Affera HW REL team with full lifecycle scope and a focus on released product engineering and quality response. Primary responsibilities will include Design Change, Design Verification, Risk Management, OEM/CM Supplier Change support, and risk response (Issue Evaluation/PHO/HRA/FCA). The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team.

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.

Required Qualifications

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

Preferred Qualifications

• Medical Device Experience
• 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
• Experience managing a QMS procedure/process
• Additional product Reliability responsibilities may be included, primarily focused on Affera Capital (HW) equipment DRM, change management, risk management, and risk response

Physical Job Requirements

U.S. Work Authorization & Sponsorship

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Benefits & Compensation

Salary ranges for U.S (excl. PR) locations (USD):$84,800.00 - $127,200.00