Teams at BiVACOR, Inc.

Own electrical manufacturing process development and improvement for PCBA, cable/harness, controller, and battery assemblies. Lead IQ/OQ/PQ/PPQ and test method validation while ensuring FDA QSR and ISO 13485 compliance. Investigate electrical assembly nonconformances using root-cause and fault-tree methods, maintain manufacturing documentation, and partner with Electrical R&D, Quality, and Regulatory teams. The role requires Class III or active implantable medical device experience and offers growth toward supplier quality and broader process leadership.

Develop, optimize, and implement scalable manufacturing processes for an implantable total artificial heart. Lead process validation (IQ/OQ/PQ/PPQ), equipment design/validation, Lean/Six Sigma improvements, CAPA investigations, documentation (BOMs, work instructions), cross-functional production support, and ensure compliance with ISO 13485, FDA, and GMP standards.

Senior manufacturing engineer responsible for designing, developing, and validating scalable production processes for an implantable total artificial heart. Leads process validation (IQ/OQ/PQ/PPQ), automation, tooling procurement, GMP/ISO 13485 compliance, NC/CAPA investigations, cross-functional projects, mentorship, and manufacturing strategy to support commercialization and regulatory readiness.