Senior Manufacturing Engineer, Electrical Systems

BiVACOR Inc•Huntington Beach, CA

9d•$120,000 - $155,000•Onsite

About The Position

BiVACOR is seeking a Senior Manufacturing Engineer with strong electrical engineering fundamentals and hands-on process validation ownership to help transition their electrical manufacturing processes (PCBA, cable/harness, controller assembly, battery systems) from development into validated, compliant production. This is a technical ownership role focused on electrical assemblies, requiring the ability to understand electrical components at a deep level and to build and defend validation packages (IQ/OQ/PQ/PPQ) demonstrating manufacturability and compliance.

Requirements

BS in Electrical Engineering (or closely related field)
5+ years in electrical manufacturing engineering with PCBA, cable/harness, or electronic sub-assembly
Class III (or active implantable) medical device experience
Direct, hands-on ownership of process validation: IQ/OQ/PQ/PPQ, pFMEA, or test method validation
Working knowledge of ISO 13485 and FDA QSR

Nice To Haves

MS degree
Familiarity with IPC-610 and IPC-620 or WHMA-A-620
Exposure to supplier qualification/auditing for electronic components
Lean/Six Sigma experience
Experience mentoring junior engineers

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