Senior Quality Engineer - Medical Devices (Cardio/Ablation)

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

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.