Senior Electrical Manufacturing Engineer, Medical Device

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

Health Savings Account (HSA) & FSA

Life insurance & Employee Assist.

Generous paid time off

Job summary

BiVACOR Inc. in Huntington Beach, CA, is seeking a Senior Manufacturing Engineer to own electrical manufacturing processes (PCBA, harness, controller assembly, battery systems) from development to validated production.

The role demands hands-on ownership of IQ/OQ/PQ/PPQ, pFMEA, and test method validation, with strong ISO 13485 and FDA QSR familiarity; direct experience with Class III medical devices is required.

Qualifications

• BS in Electrical Engineering; MS a plus.
• 5+ years in electrical manufacturing engineering with PCBA/cable/harness.
• Class III medical device experience required; ownership of validation.

Responsibilities

• Own electrical manufacturing process development across PCBA, harness, controller, and battery pack assembly.
• Lead IQ/OQ/PQ/PPQ validation and test method validation for electrical processes.
• Investigate NC/CAPA using root cause and fault-tree methods.
• Author and maintain BOMs, work instructions, solder/crimp specs, test procedures.
• Partner with Electrical R&D, Quality, and Regulatory as the manufacturing voice.

Skills

Electrical engineering fundamentals

Process validation

Root cause analysis

Documentation

Education

B.S. in Electrical Engineering

Tools

IPC-610/IPC-620 knowledge

ISO 13485 familiarity

FDA QSR familiarity

Job description

BiVACOR Inc. in Huntington Beach, CA, is seeking a Senior Manufacturing Engineer to own electrical manufacturing processes (PCBA, harness, controller assembly, battery systems) from development to validated production.

The role demands hands-on ownership of IQ/OQ/PQ/PPQ, pFMEA, and test method validation, with strong ISO 13485 and FDA QSR familiarity; direct experience with Class III medical devices is required.