Principal Reliability Engineer

Assure the timely, accurate and independent evaluation of product performance and safety prior to clinical studies or market release.
Provide support for released products, evaluate field performance and recommend corrective action when necessary.
May provide leadership to others.
This job description may include multiple disciplinary functions; Reliability Assurance, Material Quality Assurance, Quality Assurance.

Prepare, review and approve Qualification Test Plans and Reports for assigned projects. Provide technical support for technicians performing the testing. Assure the resolution of all issues raised by the testing.
Prepare, review and approve Reliability Predictions for assigned projects.
Review and approve changes to products in production for reliability impact to aid in the correction of process, design or materials problems.
Evaluate field performance of assigned products by reviewing field data, supporting technicians to evaluate unusual returns and supporting Technical Services and Consumer Affairs in responding to customers.
Support Materials Quality Engineering by providing reliability input in the evaluation of discrepant material and in the qualification of new material to assure that device reliability requirements are met.
Support Regulatory Affairs by providing reliability input in the evaluation of MDRs and submissions of requests for approval to the FDA.
Investigates and evaluates product field problems. This includes preparing Product Anomaly Evaluation Reports and Health Hazard Analysis and working with Marketing, Product Development and Regulatory on field action plans.
Maintain expertise in international safety standards and serve as a resource to assist in the development of products that meet all international requirements.
Take on special projects in which only the results are specified and complete them on schedule. This may involve making presentations/recommendations to management.
Make customer visits to resolve product issues.
May supervise technicians and/or engineers.

Minimal Requirements: B.S. in Engineering or related field with 7 years experience Strong verbal/Written communication skillsUnderstands basic principals of reliability engineering, and working knowledge of statistical techniques.Experience in customer focused qualityUnderstands typical customer use of pacing products

 

Preferred Requirements:Customer service and influence managementQuality or reliability engineer certification