Reliability Engineer II

Bachelor’s Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality, OR advanced degree in Engineering, Science or technical field.

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.

Electrochemistry / battery knowledge and experience.
Experience in a medical device manufacturing environment.
Working knowledge of ISO 13485, ISO 14971 and 21 CFR 820.
Working experience with internationally certified quality systems, USFDA Quality System Regulation or other mature regulatory or process models.
ASQ Certification in Quality or Reliability.
Hands on experience in reliability test design, execution and data analysis.
Strong communication skills (be able to work with other functions effectively).