Packaging & Sterilization Engineer

BiVACOR Inc•Huntington Beach, CA

7d•$120,000 - $127,000

About The Position

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.

Requirements

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

Nice To Haves

Six Sigma Green Belt or Black Belt preferred

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