Senior Reliability Engineer – Hardware, Electrical

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.

• 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.