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