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Reliability Engineer II - Exempt

Reliability Engineer II - Exempt

LancesoftMounds View, MN, US
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Join our innovative team in Mounds View, MN, where you'll have the opportunity to work on cutting-edge projects in a hybrid setting, collaborating with experts in the field.

Must Have Skills

  • Critical Thinking
  • Proficiency in Microsoft Office Suite
  • Experience in quality or systems engineering, test engineering, or software development

Nice to Have Skills

  • 6 Sigma, DFSS
  • Medical device industry experience

    • Responsibilities

    Responsibilities may include the following and other duties may be assigned :

  • 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.

    • Desired Skills

  • 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.
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    Reliability Engineer • Mounds View, MN, US