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Sr Engineer II - Reliability and Processing

Orange County Metro Area, CA

Posted: 07/24/2018 Job Type: Scientific Job Number: JN -072018-22120
Duties:Sr Engineer II - Reliability and Processing

Position Summary:
  • Supports project teams by executing and documenting product verification testing relating to environmental, transportation, and life (simulated use)
  • Reviews/critiques product designs, proposed processes, and testing regimens with the objective of ensuring a rigorous focus on reliability, quality, and compliance throughout development process
  • Contributes unique expertise in key aspects of product design, including reliability, compliance, and preproduction quality engineering design principles
  • Provides technical resources and methods to teams implementing design for reliability, and manufacturing (example: HALT chamber, robots, test selection, external labs, derating support, etc)
  • Provides essential analytical skills in statistical analysis, tolerancing/simulation, measurement science, stress testing, reliability assessment, simulation, and evaluating alternate components.
  • Ensures teams identify and execute key pre-verification characterization testing and review activities necessary for product improvement and robustness enhancement
  • Coordinates HALT, environmental, transportation, verification life testing, sterilization validations, cleaning validations, drying validations, PCBA stress screening, and other testing/V&V to ensure timely and efficacious completion of R&D development projects
  • Supports R&D MS&T group with a focus on approved MS&T-sponsored projects
  • Works with project teams to ensure DHF reports, verifications and validations are compliant, documented, and grounded in solid science.
  • >6 yrs with BS Degree or four years with a MS Degree.
  • Must include at least 4 yrs in R&D with primary focus on preproduction reliability and quality engineering activities.
  • Proven experience in the application of reliability engineering, including:
    • Some familiarity required in applying basic statistical methods
    • Must be familiar with GMP/QSR (regulations and standards)
    • Some experience required in fixturing, lab testing methods and/or equipment validation
    • Preferred familiarity with reprocessing methods and related equipment
    • Proven strong learning agility required
  • 1-2 years of experience in executing process validation, transfer of products from R&D into manufacturing, and working on multidisciplinary teams that include all functions in the manufacturing environment.
  • Proven knowledge in mechanical, electrical, or optical design principles. This person must be able to critique designs for their manufacturability.
  • Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
  • BSc. in Engineering (Chemical, Industrial, Mechanical or Electrical) or Physical/Biological Science
  • MS and ASQ Certifications in Quality Engineering and Reliability Engineering preferred.
  • ASQ CRE certification highly valued.
  • Fluent in written and spoken English, comfortable authoring detailed technical protocols and reports
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