Senior/Staff Electrical Engineer - Medical Devices

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Senior/Staff Electrical Engineer - Medical Devices

Location(s): San Diego, CA

Job Summary
We are seeking an experienced Senior/Staff Electrical Engineer to contribute to the development of Intravascular Ultrasound (IVUS) systems. As a member of an international, cross-functional engineering team, you will collaborate with electrical, transducer, systems, and ultrasound engineers to design and develop advanced medical device technologies.

The role focuses on analog and digital electronics, PCBAs, and FPGA design, with responsibilities spanning concept development, verification and validation, troubleshooting, regulatory compliance, and design transfer from R&D to manufacturing.

Key Responsibilities

• Conceptualize, design, and develop analog and digital printed circuit board assemblies (PCBAs) and FPGAs.
• Collaborate with multidisciplinary teams, including marketing, hardware, software, catheter design, and manufacturing, to define and refine requirements for next-generation intravascular ultrasound devices.
• Specify and qualify components, equipment, and design tools based on technical requirements, cost, availability, and reliability.
• Integrate components and technologies into new and existing designs to optimize system performance and effectiveness.
• Perform electrical testing, troubleshooting, and design debugging.
• Maintain comprehensive technical documentation in accordance with established quality systems and development procedures.
• Lead the development and execution of formal design verification and validation plans in collaboration with Quality and Regulatory teams.
• Support design transfer activities from Research and Development (R&D) to manufacturing.
• Conduct technical design reviews with project teams and independent technical experts.
• Ensure designs comply with applicable medical device development procedures and regulatory requirements.

Required Qualifications

• Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, or a related discipline.
• 5+ years of experience in analog and digital electronics design and development, including FPGA design.
• Strong background in Hardware Description Languages (HDL).
• Experience with FPGA design tools, schematic capture software, oscilloscopes, logic analyzers, emulators, and other electronic testing and debugging equipment.
• Experience with Electromagnetic Compatibility (EMC), Electrostatic Discharge (ESD), and signal integrity testing in accordance with international standards.
• Strong troubleshooting, analytical, and problem-solving skills.
• Excellent verbal and written communication skills.
• Ability to collaborate effectively within cross-functional teams and highly matrixed organizations.

Preferred Qualifications

• Experience in medical electronics or medical device product development.
• Familiarity with IEC 60601-1 and related medical device electrical safety standards.
• Experience with embedded software development.

Preferred Skills

• Product Development Lifecycle Management
• Verification and Validation Testing
• Technical Documentation
• Research and Analysis
• Technical Acumen
• Product Design
• Quality Specifications
• Regulatory Requirements
• Troubleshooting
• Requirements Analysis
• Hardware Engineering
• Business Acumen
• Continuous Improvement
• Stakeholder Management

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.