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Reliability Engineer Full-time Job

2 weeks ago Computing and ICT San Jose   39 views
Job Details

Experience level: Mid Level (5-8 yrs exp.)

Experience required: 5 Years

Education level: Bachelor’s degree

Job function: Engineering

Industry: Biotechnology

Total position: 1

Relocation assistance: Yes

Visa : Sponsor H1-B visa

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

Company Description
At Trendy Jobbers Limited we help organisations find staff. Our tradition of being able to streamline high-quality individuals each time precedes us.