XChange Software Inc.
Iselin, NJ
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Job Description :
Hi,
 
Please review the job description below and share your update resume if comfortable asap.
 
Position: Senior Verification and Validation Engineer
Location: Waltham MA
Duration: 12 Month
 
Job Description:
  • The Senior Verification and Validation Engineer is responsible for the preparation, execution, and documentation of testing activities in support of new product introductions. Starting from a database of requirements that encompasses our client’s product platforms.
  • Senior Verification and Validation Engineer will develop test methods, fixtures, and procedures to first characterize and subsequently formally verify product performance. Testing will be conducted at all levels, from component to sub-assembly to full system, and includes verification of performance and validation of user requirements.
  • The Senior Verification and Validation Engineer owns formal verification activities including planning, de-risking, protocol development, test execution, data analysis and report generation.
Responsibilities: 
  • Review and develop system and sub-system requirements leveraging their in-depth knowledge of the product 
  • Write detailed test procedures that evaluate product and systems against documented mechanical, electrical and software requirements 
  • Develop test methods and fixtures for all development testing including verification while collaborating with development teams or outside resources 
  • Execute the verification and validation of product design including requirements analysis, traceability, and testability assessment 
  • Prepare and execute test method and fixture qualifications. Fixtures may be mechanical, electromechanical, pneumatic, with or without software controls
Requirements: 
  • Bachelor of Science degree or equivalent in applicable engineering field; Mechanical, Electrical, BioMedical. 
  • Minimum of 4 years' experience in conducting verification and validation of electro/mechanical systems in a regulated industry. 
  • Medical device development experience along with a solid working knowledge of FDA Quality System Regulations and ISO 13485, and IEC 60601 is highly preferred