Sr. Electrical Manufacturing Engineer

Bullet Points

• PCBA, cable/harness, and electrical assembly expertise essential for success

• FDA-regulated environment experience strongly preferred

• $120,000-$155,000 per year + benefits | Onsite -Huntington Beach, Ca

Full Job Description

BiVACOR is seeking a Manufacturing Engineer IV – Electrical Manufacturing to lead and own our electrical manufacturing processes in Huntington Beach. 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.
What you need to be successful:

• BS in Electrical, Mechanical, Biomedical, or Manufacturing Engineering — MS desirable

• 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-A-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

• Can-do attitude — big picture thinking — strong cross-functional leadership and communication skills

• Willingness to work overtime and occasional weekends as needed to support BiVACOR as we grow

Key Responsibilities
Lead the design, development, and continuous improvement of electrical manufacturing processes for the BiVACOR Total Artificial Heart in an FDA-regulated, Class III medical device environment.

• 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

Ideal Background

• Medical device or other highly regulated industry manufacturing experience (Class II or III device experience preferred)

• Hands-on experience with SMT, through-hole, reflow, wave/selective soldering, conformal coating, and automated harness routing

• Hands-on experience with battery cycling protocols, formation, capacity testing, and electrochemical analysis

• Experience with automated test solutions and automated optical inspection (AOI)

• Formal or informal people leadership and mentoring experience

• Comfortable driving technical strategy in a fast-paced, evolving startup environment

A Bachelor's in a relevant engineering discipline is required. Demonstrated hands-on expertise and a track record of leading electrical manufacturing programs in regulated environments is what sets the ideal candidate apart.

Growth Opportunity

As BiVACOR scales toward commercialization, the Manufacturing Engineering team will grow significantly. This role carries direct influence over the technical roadmap and manufacturing strategy for the world's first Total Artificial Heart. If you are a senior electrical manufacturing engineer ready to make a defining impact on a life-saving technology, we encourage you to apply.