Verification and Validation Engineer
920 Winter St Greater Boston Area, Boston 02451
Position: Verification and Validation Engineer
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.
- 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