Sr. Electrical Engineer

IntePros is currently looking for a Sr. Electrical Engineer to join one of our growing Medical Device/ Manufacturing clients in Audubon, PA. The Sr. Electrical Engineer will need to be someone who is passionate about precision, obsessive about quality, and motivated by a mission to deliver breakthrough, evidence-based therapies that transform patient outcomes. If you aspire to lead innovation in implantable medical technology, this is your opportunity to make an impact.

Sr. Electrical Engineer Essential Functions

• Lead sustaining engineering efforts for existing neuromodulation products, ensuring continued compliance, reliability, and manufacturability.
• Identify and manage EOL components, including sourcing and qualifying alternate parts.
• Redesign electrical circuits and PCBs/PCBAs to accommodate component changes and improve performance or manufacturability.
• Support verification and validation (V&V) activities for design changes, including test planning, execution, and documentation.
• Collaborate with regulatory teams to support submission updates and ensure compliance with FDA, ISO, and QSR requirements.
• Investigate field issues and manufacturing challenges, perform root cause analysis, and implement corrective actions.
• Maintain design documentation, including schematics, BOMs, layout files, and change records in accordance with quality system procedures.
• Interface with cross-functional teams, including R&D, Quality, Manufacturing, and Supply Chain, to ensure seamless implementation of changes.
• Contribute to risk assessments and design reviews, ensuring robust and compliant design modifications.
• Support supplier communications and technical evaluations for alternate components and assemblies.
• Travel up to 10%, including domestic and international visits to suppliers or manufacturing sites.
  
  

Sr. Electrical Engineer Qualifications

• Bachelor’s degree in electrical engineering, or related field (Master’s preferred).
• Minimum 4 years of experience in electrical engineering. Equivalent years of experience may be substituted for the education requirement.
• 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.