Electrical Manufacturing Engineer, Implantables

BiVACOR Inc; Huntington Beach (CA); On-site; USD 120,000 - 155,000; Full time

Benefits offered by this job

401(k) with company matching

Medical, dental, and vision insurance

HSA & FSA

Life insurance

Generous paid time off

Job summary

BiVACOR Inc. in Huntington Beach, CA is seeking a Senior Manufacturing Engineer to own electrical manufacturing processes across PCBA, harness, controller, and battery pack assemblies.

You will lead IQ/OQ/PQ/PPQ validation, drive NC/CAPA resolution, and partner with R&D, Quality, and Regulatory to ensure compliant production. The role demands hands-on validation ownership and deep electrical understanding.

Qualifications

• 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

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

Skills

Electrical engineering

Process validation

PCBA

Cable harness

Controller assembly

Battery systems

Root cause analysis

Education

BS in Electrical Engineering

MS preferred

Tools

IPC-610

WHMA-A-620

IPC-620

ISO 13485

Job description

BiVACOR Inc. in Huntington Beach, CA is seeking a Senior Manufacturing Engineer to own electrical manufacturing processes across PCBA, harness, controller, and battery pack assemblies.

You will lead IQ/OQ/PQ/PPQ validation, drive NC/CAPA resolution, and partner with R&D, Quality, and Regulatory to ensure compliant production. The role demands hands-on validation ownership and deep electrical understanding.