Senior Electrical Engineer
On-site · Audubon, Pennsylvania, United States
Job Summary
Lead sustaining engineering efforts for neuromodulation products, ensuring continued reliability, manufacturability, and compliance. Redesign electrical circuits and PCB/PCBAs to accommodate component changes and improve performance. Support verification and validation activities for design changes, including test planning, execution, and documentation. Collaborate with regulatory teams to support submission updates and ensure FDA/ISO/QSR compliance. Investigate field issues, perform root cause analysis, and implement corrective actions. Maintain design documentation (schematics, BOMs, layout files, change records) per quality system procedures. Interface with R&D, Quality, Manufacturing, and Supply Chain to ensure seamless implementation of changes. Contribute to risk assessments and design reviews to ensure robust, compliant design modifications. Support supplier communications and technical evaluations for alternate components and assemblies. Travel up to 10% (domestic and international) to suppliers or manufacturing sites.
Required Qualifications
- Bachelor’s degree in electrical engineering, or related field (Master’s preferred)
- Minimum 4+ years of experience in electrical engineering
- Experience in medical devices or other regulated industries (e.g., aerospace, automotive) is strongly preferred
- Strong understanding of analog/digital circuit design, embedded systems, and power electronics
- Proficiency in schematic capture and PCB layout tools (e.g., Altium Designer, OrCAD)
- Familiarity with component lifecycle management and alternate part qualification
- Experience with V&V processes and regulatory documentation
- Excellent problem-solving, communication, and technical writing skills
- Working knowledge of FDA regulations, ISO standards, and QSR compliance
- Ability to manage multiple priorities and drive projects to completion in a cross-functional environment
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