Teams at BiVACOR, Inc.

Lead electrical manufacturing processes in a Class III medical device environment. Responsibilities include process validation, supplier development, and cross-functional collaboration.

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.

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.