Software Engineer--- Medical Device

Job Title: Software V&V Engineer (Danbury)
Pay Rate: $50-60/hr
Location: Danbury, CT 06810
Hours: Mon-Fri, 8am start time

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 recommends courses of action; recommends 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.