Senior Verification & Validation Engineer
Urinalysis Project
No. of Vacancies : 1
Posting Date: 20/08/2020

Job Description: 

  • Develop Design Verification and Validation plan for new product design and development
  • Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
  • Develop and execute Verification and Validation protocols that effectively challenges product design and based on System and Sub-system requirements.
  • Develop and conduct sampling procedures and statistical analysis on test data
  • Identify and investigate root cause of test anomalies and failures, raise and resolve issue logs.
  • Document test results and generate verification and validation records and reports.
  • Drive the development and construction of test equipment, jigs or fixtures whenever needed.
  • Work closely with different functions, e.g. System, Mechanical and Electrical Engineers, QA, RA and Operation team.
  • Review Design Input and Output documents. Provide inputs to the design requirements for clear, concise and testability.
  • Ensure the design considerations are embedding all applicable DFX (design for Excellence) aspects including manufacturability, usability, reliability and safety.
  • Liaise with external test labs or suppliers for conducting verification/validation tests.
  • Involve in quality control activities (including, but not limited to, FMEA, Hazard Analysis etc.)
  • Participate in Design Reviews and giving inputs to development team.
  • Understand the NCE, CAPA and Change Management.
  • Summarize data using appropriate descriptive and inferential statistics.  Collate, analyze and interpret statistical data for internal and external customers
  • Properly document activities in accordance with best engineering practices, company procedures, and regulatory requirements.

Requirements/Qualifications: 

  • Bachelor of engineering with  3 - 7 years of experience in Medical Devices Industry
  • Medical Devices/Life Science Industry experience along with the In depth knowledge in FDA / ISO requirements- such as ISO 13485/IEC 62304/ISO 14971/IEC 62366 and FDA part 820.
  • Experience in medical device verification, validation, human factor/usability tests. IVD device experience is preferred.
  • Experience with conventional inspection and measurement equipment
  • Analytical ability in problem solving
  • Good communication skills, interpersonal skills, team work.
  • Ability to work under pressure and time constraints