Lead Quality Engineer, Medical Devices — On-Site + Equity

Metric Bio; California; On-site; USD 150,000 - 210,000; Full time

Job summary

Metric Bio is recruiting a Principal Quality Engineer for its Northern California site. This on-site, full-time role offers technical ownership of quality activities across next-generation medical devices and direct exposure to senior leadership as the company expands its portfolio.

You will lead sterilization validation, biocompatibility testing, and risk management, partnering with R&D on design controls and with manufacturing on scale-up.

Qualifications

• 10+ years of Quality Engineering experience in Class II/III medical devices.
• Strong hands-on expertise in sterilization and biocompatibility.
• Experience with design assurance and design controls.
• Extensive knowledge of ISO 13485, ISO 14971 and FDA quality requirements.

Responsibilities

• Lead sterilization validation, biocompatibility testing and risk management for complex devices.
• Collaborate with R&D on design assurance, design controls, verification and validation.
• Support manufacturing scale-up, process validation and external manufacturing partners.
• Mentor engineers and strengthen internal quality capabilities.

Skills

Quality engineering

Sterilization

Biocompatibility

Design controls

FDA requirements

Catheter-based devices

Tools

ISO 13485

ISO 14971

Job description

Metric Bio is recruiting a Principal Quality Engineer for its Northern California site. This on-site, full-time role offers technical ownership of quality activities across next-generation medical devices and direct exposure to senior leadership as the company expands its portfolio.

You will lead sterilization validation, biocompatibility testing, and risk management, partnering with R&D on design controls and with manufacturing on scale-up.