Principal Quality Engineer

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

Principal Quality Engineer - Medical Devices

Full-Time | On-Site | Northern California

I'm hiring a Principal Quality Engineer for an innovative, publicly traded medical device company developing next-generation technologies for minimally invasive procedures.

With an expanding product portfolio and continued investment in product development and commercialization, this is a newly created position offering the opportunity to take technical ownership of critical quality activities, influence product development and support manufacturing scale-up.

The Opportunity

• Lead sterilization validation, biocompatibility testing and risk management across complex medical devices.
• Partner closely with R&D on design assurance, design controls, verification and validation.
• Support manufacturing scale-up, process validation and external manufacturing partners.
• Act as a technical quality expert, mentoring engineers and strengthening internal capabilities.

What I'm Looking For

• 10+ years of Quality Engineering experience within Class II/III medical devices.
• Strong hands-on expertise in sterilization, biocompatibility and design assurance.
• Extensive knowledge of ISO 13485, ISO 14971 and FDA quality requirements.
• Experience supporting catheter-based devices from development through commercialization.
• An independent, collaborative engineer comfortable working in a fast-paced, growing organisation.

Why Consider This Opportunity?

• Newly created, high-impact position with genuine technical ownership.
• Opportunity to influence innovative medical technologies from development through commercialization.
• Direct exposure to senior leadership within a growing organisation.
• Competitive compensation, annual bonus, equity and comprehensive benefits.