Principal Engineer

Senior Staff / Principal Quality Engineer

Risk Management | Orange County, CA

🚀 A well‑funded Orange County, CA MedTech startup is seeking a Risk Management Subject Matter Expert to help transition the company from rapid product development into a fully compliant FDA design control environment.

⭐ THE OPPORTUNITY

· ⭐ Build the risk management infrastructure for a growing MedTech company

· ⭐ Work directly with R&D and regulatory leadership

· ⭐ Help prepare the organization for upcoming regulatory submissions

· ⭐ Play a key role in strengthening design control and DHF documentation

🔧 WHAT YOU’LL BE DOING

· 🔧 Establish a scalable risk management framework aligned with FDA expectations

· 🔧 Lead remediation of legacy risk management documentation

· 🔧 Perform hazard analysis, risk assessments, and risk control activities

· 🔧 Ensure traceability across hazards, mitigations, and verification activities

· 🔧 Support DHF remediation and design control alignment

✅ WHAT THEY’RE LOOKING FOR

· ✅ 8–15+ years in medical device Quality or R&D

· ✅ Hands‑on ownership of ISO 14971 risk management

· ✅ Strong understanding of FDA Design Controls and QSR/QMSR

· ✅ Experience building or remediating risk management systems

· ✅ Background supporting Class II or Class III devices with software

➕ NICE TO HAVE

· ➕ Global design transfer experience

· ➕ Electrophysiology, catheter-based systems, or other high‑risk devices

📩 Interested or know someone who might be a fit? Let’s connect.