Reliability Engineer II - Exempt
- Mounds View, MN
- Permanent
- Full-time
- Critical Thinking
- Proficiency in Microsoft Office Suite
- Experience in quality or systems engineering, test engineering, or software development
- 6 Sigma, DFSS
- Medical device industry experience
- Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
- Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
- Complete risk analysis studies of new design and processes.
- Compile and analyze performance reports and process control statistics; investigate and analyze relevant variables potentially affecting product and processes.
- Ensure that corrective measures meet acceptable reliability standards.
- Analyze preliminary plans and develop 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.
- Propose changes in design or formulation to improve system and/or process reliability as necessary.
- Determine units and/or batches requiring environmental testing and specify the minimum number of samples to obtain statistically valid data.
- 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.
- Understanding of and experience in the application of statistics, including experience with Minitab.