🛠 Tech Stack

💼 About This Role

You'll lead design quality engineering for Cleerly's AI-driven software medical devices in a remote healthcare company. You'll ensure compliance with ISO 13485, IEC 62304, and FDA regulations while collaborating with cross-functional teams. This role offers the chance to impact heart disease diagnosis and treatment at scale.

🎯 What You'll Do

• Lead design quality engineering for SaMD projects.
• Review and approve design control documentation.
• Facilitate risk management per ISO 14971.
• Maintain Design History File for audits.

📋 Requirements

• Bachelor's in engineering or related discipline.
• 12+ years in Design Quality for medical devices.
• Expert knowledge of ISO 13485 and IEC 62304.
• Experience with FDA QSR and global regulations.

✨ Nice to Have

• ASQ certification (CSQE, CQE).
• Experience with GitHub, TestRail, CI/CD.

🎁 Benefits & Perks

• 🏖️ Remote-first work environment
• 🏥 Health insurance coverage
• ✈️ Travel for team meetings (2x/year)
• 💰 Equity in a funded startup

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter Call· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical Panel· 60 min
4. 4Offer· 30 min