Our Medical Device client is hiring! The team is seeking Reliability Engineer II candidates to support product testing and reliability engineering activities. Candidates should have 2-4 years of experience working in a Medical Device setting, exposure to Reliability Engineering, and previous experience characterizing test methods and executing Test Method Validation.
Reliability Engineer II (Through end of April 2025 // Boston, MA):
Top Skills:
Basic understanding of 21 CFR 820 and experience working in the Medical Device Industry
Test Method Development and Analysis
Reliability Engineering
Test Method Validation
Duties:
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 Knowledge and Experience:
Requires a University Degree and minimum of 2-4 years of relevant experience, or advanced degree with 1-2 years of experience.