Software Verification & Validation (V&V) Engineer

· Bachelor's Degree required.

· You must_ need 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

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.

Job Type: Contract

Pay: $50.00 per hour

Experience level:

• 7 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• medical device validation: 7 years (Required)
• project management: 7 years (Required)
• electronic owner manuals: 7 years (Required)
• tests software and hardware requirements: 7 years (Required)
• Troubleshoots product problem: 7 years (Required)
• root cause analysis.: 7 years (Required)
• Regulatory Affairs for 510k: 6 years (Required)
• laboratory notebooks: 7 years (Required)
• V and V technical plans and protocol: 7 years (Required)
• SOPs: 7 years (Required)
• FDA guidelines: 7 years (Required)

Work Location: In person