Verification and Validation Engineer

Greater Boston Area, Boston

Posted: 01/18/19 Category: Professional Job Number: 7359

Position: Verification and Validation Engineer

Job Description
In this role, you have the opportunity to Design, development, documentation and execution of all design verification & validation (V&V) plans, schedules, test protocols and reports to ensure business meets published specifications and are compliant with Quality System Regulations. This engineer will work on medical device products. This role is for a seasoned Software Quality Engineer with extensive experience in automation to help develop automation protocols.

You are responsible for
  • Responsible for developing and executing V&V test plans and compiling results in accordance with processes.
  • Develops risk-based and statistically significant sampling plans for technical requirements.
  • Participates in a cross functional team supporting design reviews, hazard analysis and risk assessments to ensure high standards are met.
  • Participates in root cause analysis for defects and provides process improvement suggestions to eliminate future occurrences of similar defects.
  • Uses Defect Tracking System to 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 design controls and associated processes.
  • Maintains current knowledge in latest testing methodologies.
  • Maintains current knowledge to ensure compliance to applicable regulatory and corporate domestic and international standards/requirements (e.g., FDA QSR, ISO 13485, MDD) as they apply to V&V activities of the Design Control process.

Required:
  • This consultant will come from a thorough Medical Device background and should have extensive experience working with Software Quality, Computer Systems Validation, etc.
  • They should be well-versed in automation and capable of creating new automation protocols.
  • They will also shift existing automation protocols, while ensuring tests run cleanly, verify and validate models, etc.
  • They should also possess experience with Windows based computer software from an automation perspective.
  • B.S. or M.S. in Computer Science, Mechanical or Electrical Engineering or similar related field
  • 7+ years of medical device experience
  • 5+ years of verification experience
  • Software Quality Engineering
  • Experience with automation is a must.
  • Windows experience from automation perspective
  • Engineering / R&D experience in rigorous quality-focused environment
  • Excellent oral, written and presentation skills
  • 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

Kathryn Egizi
Technical Recruiter

Contact Kat today to learn more about this terrific opportunity with Queen Consulting Group!

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