Verification and Validation

1 day ago

El Dorado Hills, California, United States EMED Technologies Full time

About the role

  • The primary duty of the V&V Engineering Technician is to support new products developmental and legacy device validation testing to characterize performance and to compile data for global regulatory submissions. Support QA and RA in all aspects of the QMS to meet the requirements. 
  • This position reports to the Director of R&D and Engineering  

What you'll do

  • Responsible for performing verification and validation testing of infusion medical devices to support regulatory submissions, design enhancements, and product launch. 
  • Generate validation protocols, testing, data analysis and reporting 
  • Generate and update technical documentation  
  • Develop new and optimize existing test protocols that align with EMED's QMS. 
  • Coordinate development of prototypes.  
  • Author ad-hoc summaries and reports based on observations and test results to drive device design enhancements and for use in the development of future test protocols. 
  • Participate in investigations and execute tasks related to nonconforming material, complaint investigations, audit observations and Corrective and Preventive Actions (CAPA). 
  • Assist with preparation of documents for regulatory submissions. 
  • Assist with calibration activities of test equipment when necessary. 
  • Maintain effective communications with design team internally and externally, including clinicians and patients when necessary. 
  • Assist with manufacturing process validation 

Qualifications

  • Bachelor of Science in Engineering or related technical field is preferred. 
  • Basic understanding of Medical Devices development under 21 CFR 820 and ISO 13485 
  • Minimum 2 years of medical devices testing experience, other non-medical devices experience is acceptable.
  • Ability to create read and understand test protocols and reports using scientific methods and applicable medical device regulations. 
  • Ability to read and understand drawings, and schematics. 
  • Good technical and troubleshooting skills. 
  • Human Factors Engineering Validation is ideal. 
  • Knowledge of basic engineering principals in the mechanical, electrical, and quality fields. 
  • Basic knowledge of statistical terminology and methods for analyzing test data 
  • Ability to rely on experience and judgment to plan and accomplish goals. 
  • Must be able to use computers, calculators, diagnostic test equipment, and precision measuring equipment. 
  • Good organization and planning skills. 
  • Ability to coordinate workload with team members in a fast-paced, internally and externally. 
  • Ability to read and interpret documents such as safety data sheets, technical data sheets, operating and maintenance instructions and procedure manuals. 
  • Ability to carry out instructions furnished in written, oral or diagram form. 
  • Experience with Microsoft Office (MS Excel, Word, Outlook and PowerPoint). 

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