Reliability Engineer- Medtech
Life Science Medtech Consulting, Lake Forest, CA, United States
Job Title:
Reliability Engineer Location: Lake Forest, CA Duration: Long term Job Description
A Reliability Test Engineer at on‑site, in Lake Forest, California, to work on reliability enhancement of product design for Valeda including improvements of product reliability using various engineering tools, compliance to environmental/transportation requirements, effective utilization of simulation/analysis methods, and DfX engineering design principles. Qualifications
≥5 years with a BS Degree or 3 years with an MS Degree in ME, EE, or Biomedical Engineering. At least 3 years in R&D with a primary focus on new product reliability engineering activities. Proven knowledge in Mechanical, Electrical, or Optical Design Principles. Proven experience in the application of reliability engineering, including familiarity with basic statistical methods. Familiarity with GMP/QSR regulations in the Medical Device industry. Knowledge of embedded systems, communication protocols for CAN bus and Ethernet. Practical experience in test automation and programming (SW such as LabView, Python, and R). Experience with fixturing, lab testing methods, robotics and/or equipment validation. Strong learning agility. Responsibilities
Deliver end‑to‑end characterization and V&V compliance support on site at the Companies office at Lake Forest, CA. Plan and execute test strategy per reliability plan. Collaborate with NPI teams to identify and execute key pre‑verification characterization testing and other activities necessary for continuous product improvement and robustness enhancement. Plan, develop, and execute automated test scripts, LabVIEW programs, robotic programs, HALT, ALT, environmental, transportation, life testing, PCBA stress screening, engineering tests and/or V&V to ensure timely and efficacious completion of R&D development projects within budgetary and resource constraints. Ensure timely completion of testing with continuous feedback to the development team for ongoing design enhancements. Align test strategy and logistics with outside labs and company QMS. Work effectively and efficiently with internal or external labs, and product design engineers to accomplish timely and valuable results at optimal cost. Review/critiques product designs, proposed processes, and testing regimens ensuring a rigorous focus on reliability, quality, and compliance throughout NPI. Use analytical skills in statistical analysis, tolerancing/simulation, measurement science, stress testing, reliability assessment, simulation, and design critique as appropriate to support NPI Design for Reliability objectives. Work with design control functions to ensure timely corrective actions of design, assembly, supplier, or other production issues encountered during NPI. Work with project teams to produce RCR reports, verifications and validations that are compliant, documented, and grounded in solid science. Maintain lab processes, equipment and calibration. Ensure compliance with QMS processes relevant to the reliability labs, support all processes for handling and maintaining lab equipment including calibration and GMP practices, and ensure compliance to all site‑specific HSE processes and requirements including laser lab safety.
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Reliability Engineer Location: Lake Forest, CA Duration: Long term Job Description
A Reliability Test Engineer at on‑site, in Lake Forest, California, to work on reliability enhancement of product design for Valeda including improvements of product reliability using various engineering tools, compliance to environmental/transportation requirements, effective utilization of simulation/analysis methods, and DfX engineering design principles. Qualifications
≥5 years with a BS Degree or 3 years with an MS Degree in ME, EE, or Biomedical Engineering. At least 3 years in R&D with a primary focus on new product reliability engineering activities. Proven knowledge in Mechanical, Electrical, or Optical Design Principles. Proven experience in the application of reliability engineering, including familiarity with basic statistical methods. Familiarity with GMP/QSR regulations in the Medical Device industry. Knowledge of embedded systems, communication protocols for CAN bus and Ethernet. Practical experience in test automation and programming (SW such as LabView, Python, and R). Experience with fixturing, lab testing methods, robotics and/or equipment validation. Strong learning agility. Responsibilities
Deliver end‑to‑end characterization and V&V compliance support on site at the Companies office at Lake Forest, CA. Plan and execute test strategy per reliability plan. Collaborate with NPI teams to identify and execute key pre‑verification characterization testing and other activities necessary for continuous product improvement and robustness enhancement. Plan, develop, and execute automated test scripts, LabVIEW programs, robotic programs, HALT, ALT, environmental, transportation, life testing, PCBA stress screening, engineering tests and/or V&V to ensure timely and efficacious completion of R&D development projects within budgetary and resource constraints. Ensure timely completion of testing with continuous feedback to the development team for ongoing design enhancements. Align test strategy and logistics with outside labs and company QMS. Work effectively and efficiently with internal or external labs, and product design engineers to accomplish timely and valuable results at optimal cost. Review/critiques product designs, proposed processes, and testing regimens ensuring a rigorous focus on reliability, quality, and compliance throughout NPI. Use analytical skills in statistical analysis, tolerancing/simulation, measurement science, stress testing, reliability assessment, simulation, and design critique as appropriate to support NPI Design for Reliability objectives. Work with design control functions to ensure timely corrective actions of design, assembly, supplier, or other production issues encountered during NPI. Work with project teams to produce RCR reports, verifications and validations that are compliant, documented, and grounded in solid science. Maintain lab processes, equipment and calibration. Ensure compliance with QMS processes relevant to the reliability labs, support all processes for handling and maintaining lab equipment including calibration and GMP practices, and ensure compliance to all site‑specific HSE processes and requirements including laser lab safety.
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