Rani Management Services Inc

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Reliability Engineer
San Jose, CA
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Description

We are seeking a Reliability Engineer to perform hazard evaluation, failure analysis and develop risk mitigation strategies in a regulated, biotech environment.  The position will work closely with R&D, manufacturing, process, packaging and quality to provide guidance on the reliability of new product designs that will ensure sustained robustness.  The position will also lead the effort to design relevant experiments, collect/analyze data and make sound recommendations to achieve high reliability as the company grows and scales up.    

Requirements
  • Actively participate in engineering design reviews and define appropriate metrics to measure/evaluate product reliability
  • Develop/conduct Design of Experiments (DOE) and reliability studies that would lead to  understanding of multiple variables that may affect product performance    
  • Define/establish test methods and statistical process control procedures to achieve desired product reliability
  • Propose/recommend appropriate materials, components and engineering concepts that minimize or eliminate the risk of failure 
  • Determine statistical sample size required for technical reliability studies 
  • Evaluate the current manufacturing hardware/software/process and make recommendations for achieving high reliability as the company scales and gears up for increased production throughput 
  • Work with internal engineering team as well as outside service providers to qualify new components, equipment and  processes from reliability standpoint
  • Using statistical software tools such as Minitab, perform data analysis, prepare relevant presentations/documentations/reports, highlight reliability issues and make appropriate recommendations 
  • Create appropriate infrastructure and set high standards for achieving/maintaining quality and reliability      
  • Review design changes for their impact on Quality and Reliability 
  • Participate and actively contribute to continuous improvement efforts that will streamline and improve the reliability process
  • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications

  • BS degree in physics or mechanical Engineering or related technical field
  • 5-7 years of relevant engineering reliability experience in complex medical technologies
  • Must be hands-on and  be able to independently develop and perform experiments 
  • Extensive experience with mechanical/environmental stress, shock, drop, vibration and accelerated testing
  • Proven track record in a regulated environment , ISO, cGMP and QMS standards
  • Proficient with applying DOE, statistical analysis tools such as Minitab, dFMEA, pFMEA and other techniques to identify failure modes at system, sub-system and component level
  • Excellent verbal, written, presentation and interpersonal skills
  • Strong analytical and problem-solving skills 
  • Creative, self-motivated and flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications

  • MS or PhD in physics, engineering or equivalent
  • Knowledge/experience with polymers and processes such as injection molding and pressure forming
  • Familiarity with sterilization process

Travel

Up to 10%


PM20

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