VivoSense Hiring for Validation Engineer at San Diego, CA Full Time

Validation Engineer Job Description

Remote – USA

About VivoSense:

Since 2010 VivoSense has been the premier science and technology company delivering end-to-end services and solutions for clients collecting clinical data from digital health technologies (DHTs), such as wearable sensors, mobile applications, and connected health monitoring tools. Working with drug developers, healthcare providers and academics, VivoSense develops and validates real-world digital clinical measures that matter to patients, and provides advanced software, analytics, and scientific expertise to improve the quality, accuracy, timeliness and ease of data analysis and insight generation from complex DHT data.

In 2022, VivoSense secured Series A financing and we are growing our team as we evolve our software platform, establish R&D capabilities and expand our client-facing business. We are seeking a talented and motivated individual to join our science team to bring expertise and the highest levels of quality to our client partnerships.

Responsibilities:

• Support the entire Software Development Life Cycle (SDLC) to ensure activities follow design control, software development, software testing comply with applicable procedures and standards.

• Executes software validation activities to include Change Control initiation, requirements/ protocol preparation, scheduling, protocol execution, data review and final generation.
• Support software defect tracking and monitoring with the development team.

• Author validation protocols and s for off-the-shelf software, configured software, and custom software.

Requirements:

• Bachelor’s degree in Quality Management, Life Sciences or Engineering Discipline with 3+ years of industry experience.
• Experience working in a regulated Quality Management System, such as ISO 9000, ISO 13485, 21CFR820, 21 CFRPart11.
• Experience with GxP requirements.

Nice to have:

• Experience working in a Cloud Based QMS, such as Verse, ETQ, MasterControl, or ComplianceQuest.
• Experience with data privacy regulation HIPAA and GDPR.
• Experience with Risk Analysis and Management.

Salary Range: $85,000 – $105,000 (DOE)

Additional Benefits/Perks: