Reliability Engineer II
3 days ago
The Reliability Engineer 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 years of relevant experience, or advanced degree with 0 years of experience.
- Critical thinking
- Knowledge of quality management systems
- Knowledge of risk management processes
- Critical thinking and problem-solving skills, including application of structured problem-solving methods and tools.
- Written and oral communication skills, including the ability to summarize complex technical concepts and problems clearly and concisely.
- Collaboration and influence skills.
- Advanced degree in engineering, science, or equivalent field.
- Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing.
- Certified Reliability Engineer (CRE), Certified Software Quality Engineers (CSQE) or equivalent certification.
- Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA).
- Experience with Software Reliability Engineering models including growth models.
- Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
- Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications.
- Experience with automated and/or manual software tests.
- Experience with Agile or behavior-based development.
- Experience in medical devices or other regulated industry.
- Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
- Experience working with IEC 62304.
- Knowledge of Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), Design for Reliability and Manufacturability (DRM), or other robust design practices.
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