_{15th January, 2026}

Manufacturing Quality Engineer II – Process Validation

• Huntington Beach, CA
• $91,900 - $99,600 base salary (dependent on experience) + benefits
• BiVACOR -  Replacing Hearts and Restoring Lives.

Why this role

• Lead process & equipment validation for a first-of-its-kind Class III medical device
• Work hands-on in a regulated manufacturing and cleanroom environment
• Join a mission-driven team developing the world’s first long-term Total Artificial Heart

Our client, BiVACOR is a clinical-stage medical device company developing the BiVACOR Total Artificial Heart (TAH), a revolutionary solution for patients with end-stage heart failure.

As they scale manufacturing, we are seeking a Manufacturing Quality Engineer II – Process Validation to play a critical role in ensuring their processes, equipment, and test methods meet the highest standards of quality, reliability, and regulatory compliance.

This is a highly visible, hands-on role working closely with Manufacturing, Engineering, R&D, and Regulatory Affairs.

What You’ll Be Doing Validation Leadership

• Lead and execute IQ/OQ/PQ for manufacturing and laboratory equipment
• Develop and manage Process Validation strategies, including PPQ and ongoing process monitoring
• Perform Test Method Validation (TMV) to ensure accuracy, precision, and reproducibility

Regulatory & Quality Compliance

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, GMP, EU MDR, and related standards
• Author and review validation documentation including protocols, reports, and SOPs
• Support internal and external audits, regulatory inspections, and inspection responses

Manufacturing & Cleanroom Support

• Provide hands-on quality and validation support in a controlled manufacturing / cleanroom environment
• Partner with Manufacturing and Engineering to resolve validation gaps and prevent issues at the source

Risk Management & Continuous Improvement

• Apply risk-based validation approaches to prioritize activities
• Lead deviations, nonconformances, investigations, and CAPA
• Drive process improvements to enhance efficiency, yield, and compliance

Cross-Functional Leadership

• Collaborate with Manufacturing, Engineering, R&D, and Regulatory teams
• Provide technical guidance on quality and validation matters
• Train and mentor junior engineers on validation best practices

What We’re Looking For

• Bachelor’s degree in Engineering or related discipline
• 4+ years of experience in Quality / Validation Engineering within medical devices
• Strong hands-on experience with IQ/OQ/PQ, Process Validation, and TMV 
• Working knowledge of FDA QSR, ISO 13485, GMP, and regulated manufacturing environments
• Experience supporting manufacturing operations and cleanroom processes
• Strong problem-solving, documentation, and cross-functional communication skills
• Someone who can adapt to a start-up environment, collaborate with their direct and wider teams

Preferred (Nice to Have)

• ASQ Certified Quality Engineer (CQE) or CSQE
• Software Validation experience
• Exposure to automated manufacturing systems, LIMS, or ERP
• Lean / Six Sigma experience
• Proficiency with Minitab, JMP, or statistical validation tools

Why BiVACOR?

• Work on ground-breaking technology with global, life-saving impact
• Be part of a high-calibre, collaborative engineering culture
• Contribute directly to a product advancing toward human clinical studies and manufacturing scale-up
• Join a company truly living its mission: Replacing Hearts and Restoring Lives

If you’re a manufacturing-focused Quality / Validation Engineer who wants their work to genuinely matter - this is a rare opportunity.

Apply now or reach out for a confidential conversation.

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