Sr. Reliability Engineer

Position Description: Support engineering function within new product development for large development lifecycle of complex electro-mechanical & electronic medical devices. Design test methods and statistical process control procedures for achieving required levels of product reliability. Compiles and analyzes performance reports and process control statistics & investigates and analyzes relevant variables potentially affecting product and processes. Responsible for Medical Device Risk and deliverables to include Risk Analysis, Design, Use and Process Failure Mode Effects Analysis (xFMEAs), and Risk Assessment. Author reliability studies and evaluations of engineering design concepts and DOE constructs. Follow guidance within standards to include IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-2, IEC 62304, and IEC 62366. Navigate the complexities of various government and industry regulations to include FDA 21 CFR part 820, ISO 9001, ISO 13485, and ISO 14971. Coordinate Complaint and Product Failure Investigations, pre and post market root cause analysis, and CAPA. Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation and Design Transfer, and Usability and Human Factor Engineering. Develop design or test methods, mathematical models utilizing statistical tools and Reliasoft software. Leverage Predict product life by utilizing Reliability models based on Physics of Failure (PoF) Run analytical assessment from fatigue perspective. Utilize nCode and NASTRAN for the assessment. Design accelerated life testing (ALT) and highly accelerated life testing (HALT) to rapidly induce and identify failure mechanisms and extrapolate results to real-world conditions. Integrate Physics of Failure insights into reliability block diagrams (RBDs), fault tree analysis (FTA), and other reliability prediction techniques. Relocation assistance is not available for this position. Position works a hybrid model and will be onsite in Lafayette, CO – 4 days per week. #LI-DNI NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows: Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210 Basic Qualifications: Master’s degree in Mechanical, Electrical or Biomedical Engineering and two (2) years of experience as a Reliability or Quality Engineer or related occupation in reliability or quality engineering; or Bachelor’s degree Mechanical, Electrical or Biomedical Engineering and five (5) years of experience as a Reliability or Quality Engineer or related occupation in reliability or quality engineering. Must possess at least two (2) years of experience with each of the following: Reliability studies and evaluations of engineering design concepts and DOE constructs; Complaint and Product Failure Investigations, pre and post market root cause analysis, and CAPA; Product Performance Specifications, Design Verification, Design Validation and Design Transfer, and Usability and Human Factor Engineering; Developing design or test methods, mathematical models utilizing statistical tools and Reliasoft software; Predicting product life by utilizing Reliability models based on Physics of Failure (PoF) and analytical assessment from fatigue perspective; nCode and NASTRAN for the assessment; Design accelerated life testing (ALT) and highly accelerated life testing (HALT); Integrate Physics of Failure insights into reliability block diagrams (RBDs) and fault tree analysis (FTA). Relocation assistance is not available for this position. Pos ... (truncated, view full listing at source)