Principal Electrical Manufacturing Engineer

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

Benefits offered by this job

401(k) matching

Medical, dental, vision insurance

HSA & FSA

Life insurance & EAP

Generous PTO

Job summary

BiVACOR is leading the development of the world’s first total artificial heart. We seek an experienced Manufacturing Engineer to shape electrical manufacturing processes, validate them end-to-end, and drive cross-functional collaboration with R&D, Quality, and Regulatory teams.

You will mentor engineers, manage complex cross-functional projects, and apply Lean/Six Sigma to deliver high-quality, compliant devices in a regulated setting.

Qualifications

• BS in Electrical, Mechanical, Biomedical, or Manufacturing Engineering; MS desirable.
• 8+ years in electrical manufacturing with PCBA, cable/harness, and sub-assembly build.
• IPC-A-610 Class 3 required; IPC-A-620 Class 3 preferred.
• Deep knowledge of ISO 13485 and FDA QSR (21 CFR Part 820).
• Experience with IQ/OQ/PQ/PPQ validations and TMVs.
• Lean Six Sigma Black Belt preferred; PMP a plus.
• Supplier development and audits for electronic components/systems.

Responsibilities

• Lead design, development, and improvement of electrical manufacturing processes (PCBA, cable, harness, battery pack).
• Own validations (IQ/OQ/PQ/PPQ) for electrical processes with FDA/ISO compliance.
• Champion Lean and Six Sigma to reduce defects, cycle time, and rework.
• Lead NC/CAPA investigations for electrical assemblies and root-cause analysis.
• Lead supplier qualification for electrical components, PCBA, cables, batteries, and sub-assemblies.
• Conduct supplier audits and drive continuous improvement across the supply base.
• Maintain electrical manufacturing documentation including BOMs, work instructions, and test specs.
• Collaborate with Electrical R&D, Quality, Supply Chain, and Regulatory as senior manufacturing voice.
• Mentor Manufacturing Engineers at junior levels (I–III) and guide cross-functional projects.

Skills

Six Sigma Black Belt

Cross-functional leadership

Problem solving

Supplier development experience

Technical mentorship

Education

BS in Electrical/Mechanical/Biomedical/Manufacturing Eng; MS desirable

Tools

IPC-610 CIS/CIT Class 3

ISO 13485 knowledge

Job description

Help Us Build the Future of the Human Heart.

At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients another shot at life. If that's the kind of work that gets you out of bed in the morning, we think you belong here.

About the Role

This is a high-impact technical leadership role in an FDA-regulated, Class III medical device environment, specializing in PCBA, cable and harness manufacturing, controller assembly, and battery systems. As BiVACOR's subject matter expert for electrical workmanship and manufacturing quality, you will set technical direction, lead cross‑functional teams, and help bring the world's first Total Artificial Heart to patients.

Key Responsibilities

• Lead the design, development, and strategic improvement of electrical manufacturing processes including PCBA, cable and harness assembly, controller assembly, and battery pack build
• Own and lead process validations (IQ, OQ, PQ, PPQ) for all electrical manufacturing processes ensuring full FDA, ISO 13485, GMP, and IPC 610/620 Class 3 compliance
• Champion Lean and Six Sigma methodologies, driving measurable reductions in defects, cycle time, and rework across electrical assembly operations
• Lead NC/CAPA investigations for electrical assemblies, applying Six Sigma and fault tree analysis to drive root cause resolution and eliminate systemic issues
• Lead the qualification and development of suppliers for electrical components, PCBAs, cable and harness assemblies, batteries, and electronic sub‑assemblies
• Conduct supplier audits and performance reviews, driving continuous improvement across the supply base
• Establish and maintain comprehensive electrical manufacturing documentation including BOMs, work instructions, solder/crimp process specifications, and test procedures
• Lead cross‑functional collaboration with Electrical R&D, Quality, Supply Chain, and Regulatory teams as the senior manufacturing engineering voice for all electrical assemblies
• Mentor and develop Manufacturing Engineers at junior levels (I–III), providing technical guidance, coaching, and structured feedback
• Lead and manage complex, cross‑functional manufacturing engineering projects from initiation through completion

What You Bring

• BS in Electrical, Mechanical, Biomedical, or Manufacturing Engineering — MS desirable
• Medical device or other highly regulated industry manufacturing experience (Class II or III device experience preferred)
• 8+ years of engineering experience with a strong focus on electrical manufacturing including PCBA assembly, cable and harness manufacturing, and electronic sub‑system build
• IPC‑A‑610 CIS or CIT certification at Class 3 level (Required) — IPC‑A‑620 Class 3 certification strongly preferred
• Deep expertise in electrical process characterization, pFMEAs, IQ/OQ/PQ/PPQ, and TMVs — with a track record of owning validation programs end‑to‑end
• Comprehensive knowledge of ISO 13485 and FDA QSR (21 CFR Part 820) with experience supporting regulatory submissions and audits
• In‑depth knowledge of IPC‑610, IPC‑620, IPC‑600, J‑STD‑001, and WHMA‑A‑620 standards
• Advanced problem‑solving skills with structured methodology — Six Sigma Black Belt strongly preferred: PMP certification an advantage
• Demonstrated supplier development and management experience for electronic components and assemblies

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.