Packaging Engineer

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.

As a key member of our manufacturing team, you'll lead the development, validation, and continuous improvement of sterilization and packaging processes that ensure every BiVACOR Total Artificial Heart component is delivered sterile, protected, and ready for implantation, meeting the highest standards of patient safety and regulatory compliance.

Key Responsibilities

• Design, optimize, and validate sterilization processes (EtO, gamma, e-beam) for titanium-based implantable cardiac components, ensuring SAL 10⁻⁶ compliance

• Develop and validate sterile barrier packaging systems per ISO 11607, including seal integrity testing, accelerated aging, and distribution simulation

• Partner with R&D and Quality to define sterilization and packaging specifications and lead design transfer activities for clinical and future commercial builds

• Conduct bioburden monitoring, endotoxin testing, and microbial risk assessments to support sterilization dose setting and ongoing process control

• Lead IQ/OQ/PQ/PPQ validations and ensure ongoing compliance with FDA 21 CFR Part 820, ISO 13485, ISO 11135, ISO 11607, and ISO 10993

• Develop and maintain pFMEAs, risk assessments, and control plans specific to sterile packaging and sterilization processes

• Design and implement packaging fixtures, labeling systems, and cleanroom handling procedures to maintain sterile barrier integrity

• Procure and validate sterilization and packaging equipment, tools, and fixtures in a low-volume clinical-stage manufacturing environment

• Support NC/CAPA investigations related to packaging and sterilization nonconformances and drive corrective actions to closure

• Apply Lean and Six Sigma methodologies to improve sterilization cycle efficiency and packaging process repeatability

• Maintain BOMs, work instructions, process flow charts, and technical reports for audits and regulatory submissions

• Work cross-functionally with R&D, Quality, Regulatory Affairs, and Supply Chain teams

• Train and mentor production operators on sterilization protocols, packaging techniques, and contamination control practices

What You Bring

• Bachelor's in Chemical, Mechanical, Biomedical, or Materials Engineering (MS preferred)

• 5+ years of engineering experience in medical devices, with direct experience in implantable or life-sustaining devices strongly preferred

• Proven track record developing and validating sterilization processes for metal or titanium-based implantable components (EtO, gamma, or e-beam)

• Experience with sterile barrier system design and packaging validation per ISO 11607 for implantable cardiac or cardiovascular devices

• Deep expertise in pFMEAs, process characterization, and IQ/OQ/PQ/PPQ protocols with demonstrated knowledge of SAL 10⁻⁶ requirements

• Working knowledge of ISO 13485, ISO 11135, ISO 10993, and FDA quality system regulations applicable to implantable devices

• Experience with cleanroom assembly, bioburden/endotoxin testing, and contamination control in a low-volume or clinical-stage manufacturing environment

• Familiarity with early-stage process development, scale-up planning, and working within a fast-paced, clinical-stage organization

• Six Sigma Green Belt or Black Belt preferred

What We Offer

BiVACOR offers a competitive compensation package and comprehensive benefits, including:

• 401(k) with company matching

• Medical, dental, and vision insurance

• Health Savings Account (HSA) & Flexible Spending Account (FSA)

• Life insurance & Employee Assistance Program

• Generous paid time off

The expected salary range for this position based in Huntington Beach California is $120,000 - $127,000. 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.