SR Electrical Engineer, R&D, NPD
On-site · Newark, Delaware, United States
Job Summary
Senior Electrical Engineer in R&D/NPD responsible for designing, developing, modifying and evaluating components and processes for electricity generation, transmission and storage. Develop expert understanding of products for clinical practice, design and test next-generation diagnostic systems, and lead design activities including PCB/schematic work, cable/harnessing, power distribution, and CAD schematic development. Provide technical guidance through design processes, support manufacturing/service issues with systematic problem-solving, participate in design reviews, and ensure compliance with quality and regulatory standards (FDA regulations, IEC 60601-1/60601-1-2, ISO 14971). Collaborate with cross-functional teams (program management, manufacturing, reliability, design engineers) and mentor less senior engineers. Maintain design documentation, control procedures, and pursue continuous improvement initiatives such as CAPA and FMEA. Preference for advanced degree and experience in medical device lifecycle management and regulatory standards.
Required Qualifications
- Bachelor's or Master’s degree in Electrical Engineering or related field
- Experience in an FDA-regulated medical device environment beneficial
- Strong knowledge of electronic design, analog/digital circuits, PCB/PCBA manufacturing, and EMC/ISO/IEC standards
- Proficiency with CAD tools (Mentor Graphics, CADSTAR, OrCAD, Altium) and ability to create/modify documentation per design control procedures
- Ability to design/test embedded electronics and write firmware (Verilog/VHDL beneficial)
- Strong written/verbal interpersonal skills and project leadership abilities
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