ashby
Senior Manufacturing Engineer, Electrical Systems
BiVACOR
Huntington Beach, USA
Full-time
Senior · 5+ years experience
Onsite
USD 120000-155000 yearly / year
Discovered 2 days ago
PCBAIQ/OQ/PQ/PPQFDA QSRISO 13485NC/CAPABOMs
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PCBAIQ/OQ/PQ/PPQFDA QSR
Role Overview
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.
Key Skills for This Role
PCBAIQ/OQ/PQ/PPQFDA QSRISO 13485NC/CAPABOMs
Full Job Posting
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.
Core 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
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