Job Description
Job Description
Help Us Build the Future of the Human Heart.
At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients a second chance at life. If that's the kind of work that gets you out of bed in the morning, we'd love to meet you.
About the Role
We're looking for a Manufacturing Engineer III to join our team as our subject-matter expert in cleaning and contamination-control processes. If you thrive at the intersection of rigorous science, regulatory compliance, and real-world impact, this role is for you.
What you'll do as a key member of our manufacturing team, you'll lead the development, validation, and continuous improvement of cleaning processes that ensure every BiVACOR component meets the highest standards of biocompatibility and safety.
Key Responsibilities
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Design, optimize, and validate aqueous, solvent-based, ultrasonic, plasma, and wipe-down cleaning processes
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Partner with R&D to define cleanliness specifications and lead design transfer activities
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Apply Lean and Six Sigma methodologies to reduce waste and improve efficiency
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Evaluate processes for environmental sustainability and implement automation where applicable
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Design and implement cleaning fixtures, rinsing systems, and drying methods
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Procure and validate manufacturing equipment, tools, and fixtures
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Oversee equipment calibration and maintenance programs
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Lead IQ/OQ/PQ/PPQ validations and ensure ongoing compliance with FDA 21 CFR Part 820, ISO 13485, and GMP standards
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Support NC/CAPA investigations and drive corrective actions to closure
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Maintain BOMs, work instructions, process flow charts, and technical reports for audits and regulatory submissions
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Work cross-functionally with R&D, Quality, and Supply Chain teams
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Train and mentor production operators on new processes and equipment
What You Bring
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Bachelors in chemical, Mechanical, Biomedical, or Manufacturing Engineering (MS preferred)
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5+ years of engineering experience in medical devices or another highly regulated industry
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Proven track record developing and validating cleaning or passivation processes
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Deep expertise in pFMEAs, process characterization, and IQ/OQ/PQ/PPQ protocols
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Working knowledge of ISO 13485 and FDA quality system regulations
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Experience with cleanroom assembly, bioburden/endotoxin testing, and contamination control
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Six Sigma Green Belt or Black Belt preferred
What We Offer
BiVACOR offers a competitive compensation package and comprehensive benefits, including:
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401(k) with company matching
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Medical, dental, and vision insurance
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Health Savings Account (HSA) & Flexible Spending Account (FSA)
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Life insurance & Employee Assistance Program
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Generous paid time off
The expected salary range for this position based in Huntington Beach California is $120,000 - $127,00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting
Apply today and be part of something extraordinary.
BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Compensation Range: $120K - $127K