Job Description

Searching for a mid-level Reliability Engineer with 2-5 years of design quality experience within the medical device industry.

BS ENGINEERING, 2-5 YEARS OF MEDICAL DEVICE DESIGN QUALITY EXP, RELIABILITY TESTING, RISK MANAGEMENT (ISO 14971)

From the manager:

• Main responsibility is REVIEWING RELIABILITY TESTING for heart valve and PERFORMING RISK MANAGEMENT EVALUATION/ASSESSMENT for the same product.
• Looking for someone witih 2-5 years of experience working in Design Control space for medical devices (does not want 10+ year candidates)
• Will be working in design assurance group for structural heart group
• Also responsible for SHELF-LIFE TESTING
• Wants someone who can work onsite occasionally (local candidates)

Job Description:

• 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.