Reliability Engineer II - Hardware / Electrical

About the role

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.

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.
• May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

Requirements

• 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.
• 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.

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 include 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.

Skills

• Design Change.
• Design Verification.
• Risk Management.
• OEM/CM Supplier Change support.
• Risk Response (Issue Evaluation/PHO/HRA/FCA).

Benefits

For more information about Medtronic’s benefits, please visit here.

Pay

$84,800.00 - $127,200.00 USD

Schedule

Minimum of 4 days a week onsite.