Senior Software V&V Engineer (Medtech)

TL;DR

Senior Software V&V Engineer (Medtech): Ensuring the quality, safety, and regulatory compliance of AI-driven heart disease diagnostic products with an accent on Design Verification and Validation (V&V) plans. Focus on developing test strategies, performing statistical analysis of imaging data, and ensuring strict adherence to FDA and ISO standards.

Location: Virtual US (Must be based in the United States)

Base Salary: $153,000 - $179,000 + 15% target annual bonus

Company

hirify.global is a healthcare company revolutionizing heart disease diagnosis through AI-driven precision diagnostic solutions aimed at preventing heart attacks.

What you will do

• Lead Design Verification and Validation (V&V) plans in compliance with 21 CFR Part 820, ISO 13485, and ISO 14971.
• Define test strategies, protocols, and acceptance criteria for mechanical, electrical, optical, and system-level performance.
• Build complex data sets and conduct statistical and exploratory data analysis using regression and visualization.
• Create and maintain test master plans, schedules, and resource allocation across multiple device programs.
• Collaborate in SCRUM cycles, participating in design and code reviews to provide feedback on V&V deliverables.
• Manage data governance, access controls, and PHI data handling.

Requirements

• Must be based in the United States.
• 5+ years of equivalent work experience in the medical imaging industry (Product Development or Quality).
• Strong programming skills in Python specifically for data science, statistical analysis, big data, and ML stack.
• Deep expertise in quality engineering regulations: 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.
• Bachelor’s or Master's degree in Computer Science, Information Technology, or a related field.
• Strong understanding of the software development life cycle (SDLC) and testing life cycle (STLC), with expertise in JIRA.

Nice to have

• Prior experience utilizing AWS Cloud Services or equivalent enterprise cloud providers.
• Experience with Class II or Class III medical devices.
• Experience in Cardiovascular imaging systems.

Culture & Benefits

• Remote-first work environment with access to various US and international offices.
• Competitive compensation including a 15% target annual bonus and stock options.
• Collaborative digital environment using Google Workspace, Slack, and Jira.
• Culture based on core values of Humility, Excellence, Accountability, Remarkable impact, and Teamwork.