Quality Engineer, Change Controls

EPM Scientific; Palo Alto (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

EPM Scientific in Palo Alto is seeking a Quality Engineer to support design controls across the product lifecycle for next-generation medical devices.

You will maintain DHFs, risk management files, and validation activities, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971. The role collaborates with R&D on design reviews and CAPA, contributing 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.

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.

Skills

Design Controls

DHF

Risk Management

V&V

Regulatory knowledge

Education

BS in Engineering or related technical field

Job description

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