Jobs 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.

As a Clinical Training & Educational Specialist, you'll design training curricula, manage LMS content, track compliance, and coordinate global training sessions for investigational site teams.

As Clinical Operations Manager, oversee logistics for clinical trials, ensuring regulatory compliance and operational readiness at study sites, coordinating activities for the Total Artificial Heart program.

Oversee clinical trials by managing sites, ensuring compliance with protocols, training staff, and maintaining documentation and data integrity.

Manage end-to-end US IDE study operations, leading a clinical research team, ensuring regulatory compliance, and driving clinical strategies for a total artificial heart study.

Provide desktop and remote help-desk support, install/configure hardware and software, maintain inventory and ticketing, troubleshoot networking and A/V, enforce cybersecurity best practices, and ensure IT compliance in a Class III medical device environment.

The Assistant Production Expediter coordinates production activities, tracks work orders, communicates with the supply chain, and supports inventory management in a manufacturing environment.