Manufacturing Electrical Engineer II (Temporary/Contractor)

About INOVIO

INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com.

Job summary

The Temporary Manufacturing Electrical Engineer II provides technical support for investigation, analysis, and resolution of device issues identified during manufacturing and from the field. This role partners closely with Quality members to ensure issues are properly documented and addressed within INOVIO's Quality Management System (QMS). The engineer supports existing medical device products and manufacturing operations, ensuring products are manufactured in compliance with established procedures, quality standards, and regulatory requirements.

Essential job functions and duties

• Investigate product complaints, field returns, and manufacturing-related issues to determine root causes and implement corrective actions.
• Support Quality System Technical Compliance activities, including participation in Material Review Board, Non-Conforming Material Review (NCMR), and Corrective and Preventative Action (CAPA) processes.
• Troubleshoot and support PCB and PCBA manufacturing processes and related electrical assemblies.
• Evaluate, investigate, and troubleshoot electrical systems, products, components, and applications using knowledge of electronics, software, manufacturing processes, and materials.
• Resolve and document technical issues encountered during manufacturing and servicing while supporting continuous improvement (CI) initiatives in accordance with GMP requirements.
• Support manufacturing line processes, process validation, and product development efforts.
• Create and revise Manufacturing and testing work instructions, including visual aids, Specifications, Inspection procedures, and qualification documentation.
• Generate and/or review product development documentation, including plans, specifications, procedures (test, manufacturing, and quality control), reports, design review documentation, and validation records.
• Participate in design reviews.
• Provide engineering support for other departments and perform additional Manufacturing Engineering responsibilities as needed.

Minimum requirements

• Bachelor's degree in Electrical Engineering (BSEE) or Industrial Engineering (BSIE) with a strong electronics background.
• Minimum of 3 years of electrical engineering experience in a regulated manufacturing environment; medical device or biotech industry experience preferred.
• Ability to read and understand electrical schematics, PCB layouts, and mechanical drawings.
• Experience troubleshooting analog circuits, including op-amps, amplifiers, passive components, A/D and D/A converters, and opto-electrical devices.
• Experience with digital circuits, integrated circuits (IC), PCB design, and circuit analysis.
• Familiarity with servo motor controls and feedback systems.
• Proficiency using laboratory test equipment, including oscilloscopes, function generators, power supplies, and digital multi-meters.
• Experience conducting failure analysis, troubleshooting, circuit debugging, and bench top testing.
• Experience supporting manufacturing operations, production line troubleshooting, and product servicing activities.
• Working knowledge of tolerance analysis and related engineering methodologies.
• Proficiency with Microsoft Office applications.
• Experience with electronic design tools such as OrCAD CIS, LTSpice, Allegro, and PADS preferred.
• Experience with manufacturing automation systems, including Human Machine Interfaces, Programmable Logic Controllers, Latter Logic preferred.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, CE, and UL Requirements preferred.
• Experience creating and maintaining engineering documentation, manufacturing, procedures, test methods, validation protocols, and technical reports.