Senior Electrical Manufacturing Engineer – Medical Device Class III

BiVACOR; 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 is hiring a Senior Manufacturing Engineer to own electrical manufacturing processes for PCBA, cable/harness, controller, and battery pack assemblies. You will lead IQ/OQ/PQ/PPQ validation and ensure FDA QSR and ISO 13485 compliance.

Ideal candidates have 5+ years in electrical manufacturing engineering, hands‑on validation ownership, and experience with Class III medical devices. Collaboration with R&D, Quality and Regulatory is essential.

Qualifications

• BS in Electrical Engineering; 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; required.
• Direct, hands‑on ownership of 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 manufacturing

Process validation

FDA QSR / ISO 13485

PCBA

Documentation

Education

BS in Electrical Engineering

Tools

IPC-610 / IPC-620

Job description

BiVACOR is hiring a Senior Manufacturing Engineer to own electrical manufacturing processes for PCBA, cable/harness, controller, and battery pack assemblies. You will lead IQ/OQ/PQ/PPQ validation and ensure FDA QSR and ISO 13485 compliance.

Ideal candidates have 5+ years in electrical manufacturing engineering, hands‑on validation ownership, and experience with Class III medical devices. Collaboration with R&D, Quality and Regulatory is essential.