Metrology Process Development Engineer

Fremont, CA

Posted: 04/22/2019 Employment Type: Direct Hire Industry: IT Job Number: JOS000008483

This company is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers. 

You may be just who we are looking for! 

This company is growing! We're looking for a Metrology Development Engineer to join our Fremont, CA team! 


A major Northern Bay Area Medial Device manufacturer is seeking Metrology Process Development Engineer, Staff to assist in developing test methods for inspection of medical devices manufactured in a facility that is registered to ISO 13485, and in some scope accredited to ISO 17025. 

Essential Duties and Responsibilities: 

  • Be a subject matter expert in Metrology and inspection techniques applicable to vascular devices and components  
  • Understanding the fundamentals of optical and other measurement techniques but also possess solid foundation to contribute to the development of the right measurement requirement scheme for the company in process and final test and measurement efforts  
  • Be able to generate best means to answering dimensional, surface, quality, geometric attribute, defect analysis, functional testing and other measurement requirements  
  • Demonstrate best practices in optical and other Metrology techniques with off-the-shelf and in house generated test and measurement tools  
  • Ability to work in a matrix organization and contribute to the projects  
  • Be highly familiar with multitude of optical and other inspection systems and their limitations  
  • Be highly familiar with optical inspection programming schemes and techniques  
  • Possess high level of competency in reviewing, designing, and contributing to fixtures, tools, and hardware development efforts along with input into lab instrumentation and possible new technologies  
  • Firm understanding of relevant standards and calibration requirements is essential. Relevant standards include but not limited to ISO 13485, ISO 17025, ANSI/NCZL Z540-1, -2, -3, and NCSL best practices  
  • Ability to own and prove leadership qualities  
  • Strong engineering background in mechanical engineering, software engineering, and/or optics is highly desirable  
  • Ability to work with internal and external customers, demonstrating strong communication skills and goal oriented behavior  
  • Project Management skills are highly desirable 

Education and Experience: 

  • Bachelor’s degree in Engineering or equivalent  
  • Minimum 5 years of experience in Metrology, Optics, Physics, Engineering or equivalent.  
  • Formal training and experience in mechanical or electrical calibration a plus.  
  • Experience with image processing and optical system is preferred.  
  • Excellent written and oral communication skills are required.  
  • Experience in performing audits on Metrology and quality processes desired – along with root cause analysis of technical discrepancies/abnormalities.  
  • Experience in preparing laboratory documentation (work instructions, calibration procedures, analysis spreadsheets, reference documents and others) in a variety of formats including Word, Excel and PowerPoint.  
  • Familiarization, laboratory auditing and root cause and Gage R&R analysis desired. 

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