V&V Engineer

Title:  V&V Engineer
Location: Andover, MA
Duration: till year end and extendable

Description:
This position is responsible for the design, development, documentation and execution of all design verification & validation plans, schedules, test protocols and reports to ensure Medicals, Consumables and Sensors (MCS) business meets published specifications and are compliant with Quality System Regulations. 
 
 POSITION RESPONSIBILITIES: 
 • Responsible for developing and executing V&V test plans, protocols and reports in accordance with processes. 
 • Participates in a cross functional team supporting design reviews, hazard analysis and risk assessments to ensure high standards are met. 
 • Uses Defect Tracking System, report and/or resolve product issues. 
 • Participate in cross-functional project team meetings. 
 • Maintains projects and documentation according to ISO and GMP guidelines, while following the Philips design controls and associated processes. 
 • Maintains current knowledge in latest testing methodologies. 
 • Performs other related duties as assigned. 
 
 BASIC QUALIFICATIONS: 
 EDUCATION REQUIRED: 
 • B.S. or M.S. in Mechanical or Electrical Engineering or similar related field 

YEARS OF EXPERIENCE 
 • 1+ years of experience in Verification and Validation of electro-mechanical devices. 
 • 1+ years of experience in Verification and Validation under Medical Device Regulations 
 SPECIALIZED KNOWLEDGE REQUIRED 
 • Working knowledge of IEC-60601 and other common ISO standards (ISO 13485) used in testing of Medical Devices 
 
 PREFERRED QUALIFICATIONS 
 • Strong Analytical and problem solving skills 
 • Self-motivated person that can work individually and be part of a cross functional team 
 • A self-starter with a strong desire to learn new concepts and adapt quickly 

Thank you,
Sachin p.,
510-402-1063
sachin@apninc.com

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