Reliability Engineer II
Development Resource Group
The Reliability Engineer II is responsible for ensuring product safety, reliability, and performance throughout the product lifecycle. This role partners with cross-functional teams including Design, Quality, Manufacturing, Regulatory, Supplier Quality, and Operations to identify and mitigate reliability risks, support product development, investigate failures, and drive continuous improvement. The ideal candidate applies reliability engineering principles, statistical analysis, and risk management tools to enhance product quality, regulatory compliance, and patient outcomes.
Key Responsibilities
- Lead reliability activities for new product development and sustaining engineering projects.
- Develop and execute reliability plans, test protocols, and risk assessments.
- Perform reliability analyses including FMEA, FTA, DOE, and statistical data evaluation.
- Support design verification, validation, and Design for Reliability (DfR) initiatives.
- Investigate product and process failures, conduct root cause analysis, and implement corrective actions.
- Develop accelerated life testing and environmental stress testing strategies.
- Collaborate across functions to improve product, supplier, and manufacturing reliability.
- Prepare technical reports and support regulatory submissions, audits, and compliance activities.
- Drive continuous improvement initiatives focused on quality, reliability, and operational efficiency.
- Provide guidance on reliability methodologies and best practices.
- Bachelor's degree in Engineering or related technical field.
- 2+ years of experience in reliability, quality, manufacturing, or product development.
- Working knowledge of reliability engineering principles, statistical analysis, and risk management tools.
- Strong analytical, problem-solving, communication, and project management skills.
- Experience in medical device, pharmaceutical, aerospace, automotive, or other regulated industries.
- Familiarity with FDA, ISO 13485, ISO 14971, IEC 60601, or similar standards.
- Experience with statistical and reliability software such as Minitab, JMP, ReliaSoft, or MATLAB.
- Experience leading cross-functional investigations and risk reduction initiatives.
Vacancy posted 3 days ago
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