V&V Engineer | Israel

Job Title: V&V Engineer

Location: Caesarea, Israel

Reports to: V&V Manager

Department: R&D

Job Description: Working in a multi-disciplinary environment with software, control, electrical and mechanical engineers, the V&V Engineer will work on verification and validation tests planning and execution for complex electro-mechanical medical device products.


Note: The following meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

 

Key Responsibilities & Authorities:

  • Review specifications and technical design documents to provide timely and meaningful feedback.
  • Create detailed, comprehensive and well-structured V&V test plans, test protocols and reports.
  • Design, develop and execute Hardware ,system, reliability and integration tests
  • Identify, record, document and track defects during testing.
  • Develop and apply testing processes for new and existing products to meet client needs/requirements.
  • Interact closely with Development Engineers.
  • Support QA aspects of technology transfer of developed manufacturing processes and new product development from R&D to manufacturing environment

 

Education - Experience Requirements:

  • BA/BSc. degree or equivalent practical experience
  • 5+ Years of proven experience in SW & HW V&V tasks including writing & executing test plans and protocols, in medical device industry with a strong emphasis on quality assurance, problem solving, along with written and verbal skills.
  • Formal and practical knowledge of testing methodologies.Good documentation skills and ability to communicate effectively at all levels of the organization
  • Familiar with Medical Device Quality Systems, ISO 13485:2003 and CFR21 Part 820. 
  • Excellent skills in English language are required (read and write)
  • Strong technical orientation for understanding multi-disciplined systems
  • Experience with CE and FDA regulations - an advantage
  • Experience with validation processes - an advantage
  • Software – PLM (WCL), ALM (Qpack) – an advantage

 

Job Specific Skills (Languages, SW, systems, etc.'):

Excellent verbal and written communication skills (Hebrew and English).

Office proficient, experience and understanding of ERP, PLM, LMS, Doc Control systems.

 

Other Requirements for the role (% of travel, etc.):

Professional, independence, quick learner and a team player with excellent interpersonal skills 

 

Working Relationships:

Internal: R&D  departments, QA/RA, Operations and Product

External: External labs, Subcontractor, Consultant

 

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The website was last updated : 26 Nov 2018

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