Location: Remote / Hybrid

Type: Full-time

Experience: Mid-level

Role Summary

We are seeking a Quality Engineer to validate and test an AI-powered product used by MedTech Product teams in medical technology companies. This role focuses on ensuring functional accuracy, reliability, compliance-readiness, and real-world usability of AI-driven workflows in regulated environments.

Key Responsibilities

• Test AI product features for accuracy, consistency, and reliability across RA/QA/Clinician/Product use cases
• Validate AI outputs against medical device quality and regulatory expectations (e.g., design controls, risk, change management)
• Design and execute test cases for AI workflows, edge cases, and failure scenarios
• Collaborate with product and engineering teams to define acceptance criteria and resolve defects
• Support documentation, traceability, and validation evidence for regulated customers

Qualifications

• Experience in Quality, Validation, or Testing within medical devices, healthcare, or regulated software
• Familiarity with RA/QA processes (e.g., ISO 13485, FDA QSR, EUMDR, design controls, risk management, clinical literature evaluation)
• Strong analytical skills and attention to detail
• Comfort testing software and AI-driven systems (no model development required)

Nice to Have

• Experience testing AI/ML or decision-support tools
• Exposure to SaaS products used in regulated industries