Verification and Commercialization Specialist

7 hours ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeValidation Full time €90,000 - €120,000

Verification and Validation Engineer Job Description

 

  • Job Title: Verification and Validation Engineer
We are seeking a highly motivated and organized Verification and Validation Engineer to execute design verification and validation testing in support of product lifecycle management and new product development. Responsibilities: 
  1. Develops new or optimizes existing physical test methods and test fixtures to support the design verification, validation and commercialization of new medical device products and changes to existing products.
  2. Drafts engineering technical reports, test method work instructions or procedures and test method validation related documents.
  3. Leads/executes test method validation (TMV), design verification and test method transfer, in support of product design verification or validation
  4. Authors design verification protocols to satisfy product design inputs/system requirements, that satisfy applicable Quality System (QS) and regulatory requirements
  5. Manages and tracks product configurations through design verification and validation
  6. Performs hands-on and simulated testing for design verification and test method developments
  7. Conducts functional and performance testing of products to ensure that the product and its components meet the required specifications
  8. Identifies and reports out of specification results, data, and atypical/unexpected events that occur during testing activities and supports associated investigations, impact assessments and Root Cause Analysis (RCA)
 Requirements and Qualifications
  • Minimum of Bachelor's degree in Engineering
  • 3+ years of professional experience in the medical device, pharmaceutical or life sciences field
 Relevant Experience
  • Applied experience in developing and qualifying test systems and methods in support of product development and launch (IQ, OQ, Measurement Systems Analysis (MSA), etc.)
  • Experience with executing Design Verification
  • Experience in statistical data analysis methods / tools, e.g.: Gage R&R, Hypothesis Testing
 Knowledge, Skills and Abilities
  • Disciplined and well organized
  • Excellent multi-tasking, analytical, communication, and prioritization skills

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