Software V&V Engineer

Duration: 12 Months

Description:

• Shift Hours: 40 hour, 5 day 8 hour, Mon-Frid, 8am start time
• WORK SITE: Danbury
• CAN THE WORKER WORK REMOTE: No
• Bachelor's required
• Candidate needs med device validation experience.
• Must have proven track record of project management.
• Needs to be self-driven fast paced and able to create solutions to avoid/conquer road blocks. Knowledge of electronic owner manuals process will be benefit of project.

Summary of Duties and Responsibilities:

• Plans, writes test cases, test reports, and tests software and hardware requirements.
• Troubleshoots product problems, improvements or field complaints.
• Assists with root cause analysis.
• Reviews data and recommend courses of action; recommend project priorities.
• Supports Regulatory Affairs for 510k.
• Performs laboratory work to assure completion in accordance with established safety procedures and applicable regulatory regulations.
• Monitor and maintain laboratory notebooks.
• Develops instructions and documentation for manuals, V and V plans and acceptance criteria documents.
• Ensures software validation procedures and guidelines are maintained and kept current with FDA guidelines.
• Develops V and V technical plans and protocols.
• Interfaces with programming staff, marketing and QA.
• Reviews SOPs for regulatory compliance.
• Assists with creation of Tools validation protocols.
• Executes complex test protocols.