Senior Manufacturing Engineer, Electrical Systems

About the role

BiVACOR is building the world's first Total Artificial Heart a Class III, FDA-regulated active implantable device. We're looking for a Senior Manufacturing Engineer who combines strong electrical engineering fundamentals with hands-on process validation ownership, to help take our electrical manufacturing (PCBA, cable/harness, controller assembly, battery systems) from development into validated, compliant production. This is a technical ownership role, not a generalist one: we need someone who can look at a board, harness, or controller assembly and understand it at the electrical level, and who can build and defend the validation package (IQ/OQ/PQ/PPQ) that proves it's manufacturable and compliant.

Responsibilities

• Own electrical manufacturing process development and improvement across PCBA, cable/harness, controller, and battery pack assembly
• Lead process validation (IQ/OQ/PQ/PPQ) and test method validation for electrical manufacturing processes, ensuring compliance with FDA QSR (21 CFR 820) and ISO 13485
• Investigate and resolve electrical assembly nonconformances (NC/CAPA) using root cause and fault tree methods
• Author and maintain manufacturing documentation: BOMs, work instructions, solder/crimp specs, test procedures
• Partner with Electrical R&D, Quality, and Regulatory as the manufacturing engineering voice on electrical assemblies

Requirements

• BS in Electrical Engineering (or closely related field); MS a plus
• 5+ years in electrical manufacturing engineering with PCBA, cable/harness, or electronic sub-assembly
• Class III (or active implantable) medical device experience; this is required, not preferred
• Direct, hands-on ownership of process validation: IQ/OQ/PQ/PPQ, pFMEA, or test method validation
• Working knowledge of ISO 13485 and FDA QSR

Skills

• Familiarity with IPC-610 and IPC-620 or WHMA-A-620 (we'll