Summary

cGMP Consulting, Inc. is seeking a subject matter expert who can lead the FEP activities for generators. This person would be responsible for designing, developing, and testing electrical components and systems, while adhering to FDA regulations, collaborating with cross-functional teams, and ensuring the quality and functionality of the system throughout the design and manufacturing process.

cGMP Consulting is looking for an individual who is efficient, comfortable working independently, and who will handle multiple projects and priorities, work with tight deadlines, and address high priority requests. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment. Assuring a steady and accurate completion of the workload on time is key to success in this position.

Responsibilities

• Lead FEP activities for backup generators.
• Perform benchtop testing, system-level testing, and design verification to ensure product functionality and compliance with regulatory requirements.
• Identifying and resolving technical issues during development and production phases.
• Working closely with other engineering disciplines and cross-functional teams like quality assurance.
• Understand and adhere to FDA regulations and industry standards related to medical device design and manufacturing.
• Create detailed technical documentation including design specifications, test reports, and design verification plan.

Requirements

• Minimum 4-year degree in Electrical Engineering or related field.
• 5-7+ years of relevant experience in electrical design and development.
• Knowledge of medical device regulations (FDA) and quality standards.
• Strong project management skills, organizational skills, and computer knowledge.