Job Description
Software V&V Engineer
Summary of Duties and Responsibilities:
Notes:
Benefits:
About The Company:
#LI-GTT
- Pay rate up to $60/hr
- Contract Duration 12+ months
Summary of Duties and Responsibilities:
- The Software V&V Engineer plans, and writes test cases, and test reports, and tests software and hardware requirements.
- Troubleshoots product problems, improvements, or field complaints.
- The Software V&V Engineer assists with root cause analysis.
- Reviews data and recommends courses of action; recommends project priorities.
- Supports Regulatory Affairs for 510k.
- Performs laboratory work to ensure completion in accordance with established safety procedures and applicable regulatory regulations.
- Monitor and maintain laboratory notebooks.
- Develop 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.
- Develop V and V technical plans and protocols.
- Interfaces with programming staff, marketing, and QA.
- Reviews SOPs for regulatory compliance.
- Assists with the creation of tool validation protocols.
- Executes complex test protocols.
Notes:
- Bachelor's required
- The candidate needs med device validation experience.
- Must have a proven track record of project management.
- Needs to be self-driven and able to create solutions to avoid/conquer roadblocks.
- Knowledge of the electronic owner manuals process will be beneficial for the project
- Shift Hours: 40 hours, 5 days 8 hours, Mon-Frid, 8 am start time
- Work Site: Danbury
- Workers work Remotely: No
Benefits:
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About The Company:
- Our client is an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While they Clients and develop groundbreaking products and services that benefit everyone, they are especially passionate about those that advance women’s health and well-being. This allows us to be a company that prospers, grows, and empowers women to experience healthier lives.
- What powers their growth across Breast and skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions is also what differentiates them: the exceptional and clinically proven ability of their products to detect, diagnose, and treat illnesses and other health conditions earlier and better.
- None of this would be possible without the talent, skills, and aspirations of their employees. Their proficiency and commitment to develop and share more robust, science-based certainty drives the company’s increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families, and communities.
#LI-GTT