Electrical Manufacturing Engineer

About the Company

BiVACOR is developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We are a team united by purpose, working on something truly unprecedented.

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 to drive reductions in defects, cycle time, and rework
• Lead NC/CAPA investigations for electrical assemblies using Six Sigma and fault tree analysis
• Lead the qualification and development of suppliers for electrical components, PCBAs, and electronic sub-assemblies
• Establish and maintain comprehensive electrical manufacturing documentation including BOMs, work instructions, and test procedures
• Mentor and develop junior Manufacturing Engineers

Requirements

• BS in Electrical, Mechanical, Biomedical, or Manufacturing Engineering
• Medical device or highly regulated industry manufacturing experience (Class II or III preferred)
• 5+ years of engineering experience focused on electrical manufacturing (PCBA, cable/harness, electronic sub-systems)
• Deep expertise in electrical process characterization, pFMEAs, IQ/OQ/PQ/PPQ, and TMVs
• Comprehensive knowledge of ISO 13485 and FDA QSR (21 CFR Part 820)
• In-depth knowledge of IPC-610, IPC-620, IPC-A-600, J-STD-001, and WHMA-A-620 standards

Benefits

• 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