Senior Manufacturing Engineer, Electrical Systems

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

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
• Partner with Electrical R&D, Quality, and Regulatory as the manufacturing engineering voice on electrical assemblies

What You Bring — Required

• 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

What You Bring — Preferred (not Required To Apply)

• Familiarity with IPC-610 and IPC-620 or WHMA-A-620 (we'll support depth here on the job)
• Exposure to supplier qualification/auditing for electronic components
• Lean/Six Sigma experience
• Experience mentoring junior engineers

What This Role Grows Into

Over time, this role has a path toward broader ownership of supplier quality, cross‑team process leadership, and mentoring junior manufacturing engineers as the team scales but you won't be expected to own all of that from day one.

What We Offer

• 401(k) with company matching
• Medical, dental, and vision insurance
• Health Savings Account (HSA) & Flexible Spending Account (FSA)
• Life insurance & Employee Assistance Program
• Generous paid time off

The expected salary range for this position based in Huntington Beach California is $120,000 - $155,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting

BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.