Quality Engineer, Change Controls

Quality Engineer, Design Controls

Palo Alto, CA (On-Site)

We're partnering with a fast-growing medical device company developing next-generation interventional ablation technology that has the potential to transform procedural precision and patient outcomes. Based in Palo Alto, the organization is advancing innovative products toward commercialization and offers the opportunity to make a direct impact in a highly visible role.

Responsibilities

• Support Design Control activities throughout the product lifecycle
• Maintain DHFs, traceability matrices, and risk management documentation
• Partner with R&D on design reviews, V&V, and product development activities
• Support CAPA, nonconformance investigations, and root cause analysis
• Ensure compliance with FDA, ISO 13485, and ISO 14971 requirements
• Contribute to NPI and commercialization efforts

Qualifications

• BS in Engineering or related technical field
• 5+ years of medical device Quality Engineering experience
• Strong Design Controls, DHF, Risk Management, and V&V experience
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971
• Experience supporting Class II and/or Class III medical devices

Preferred Background

• Cardiovascular, Electrophysiology, Structural Heart, Catheter-Based, or Ablation Devices
• Commercialization or New Product Introduction experience

If you're interested in helping bring groundbreaking medical technologies to market, please apply now.