Senior Manufacturing Engineer, Electrical Systems

The role

This person will own electrical manufacturing process development and improvement for PCBA, cable/harness, controller, and battery pack assembly. They will lead process validation and test method validation to ensure compliance with FDA QSR and ISO 13485.

What you will do

• 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
• 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

Required qualifications

• BS in Electrical Engineering (or closely related field)
• 5+ years in electrical manufacturing engineering with PCBA, cable/harness, or electronic sub-assembly
• Class III (or active implantable) medical device experience
• Direct, hands-on ownership of process validation: IQ/OQ/PQ/PPQ, pFMEA, or test method validation
• Working knowledge of ISO 13485 and FDA QSR

Nice to have

• MS a plus
• Familiarity with IPC-610 and IPC-620 or WHMA-A-620
• Exposure to supplier qualification/auditing for electronic components
• Lean/Six Sigma experience
• Experience mentoring junior engineers

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

About the company

BiVACOR is building the world's first Total Artificial Heart a Class III, FDA-regulated active implantable device.