Engr, Product Development

Join Our Innovative Product Development Team in San Diego, CA

We are seeking a highly skilled and motivated individual to provide strong technical expertise and engineering support for the design and development of new and existing medical device products. Located in the vibrant city of San Diego, CA, this role offers the opportunity to work in a dynamic environment that values innovation and quality.

Your responsibilities will include supporting current products by ensuring quality, manufacturing efficiency, supply continuity, and cost improvements. You will participate in technical and cross-functional project execution while fostering a culture of innovation through the proactive generation of new product concepts and enhancements to existing product performance.

Key responsibilities include:

• Understanding customer needs through literature reviews, interviews, direct observation, competitive analysis, prototype evaluations, and clinical or simulated use studies.
• Translating customer needs into engineering requirements and developing specific product, packaging, and process specifications.
• Applying engineering fundamentals to design robust, manufacturable products.
• Developing and executing test methods, including defining measurement equipment, test setups, measurement system analysis, and data analysis.
• Preparing detailed technical reports based on design verification, testing, and analysis for design changes and product development activities.
• Ensuring compliance with company quality policies, procedures, and practices, as well as all applicable local, state, federal, and safety regulations.
• Providing technical leadership and fostering professional growth within the team.

Technical expertise required:

• Analog and digital circuit design for medical devices
• Low-power design for battery-operated devices
• Knowledge of IEC 60601 and ISO 13485 standards
• EMC/EMI compliance and testing experience
• PCB design and layout (Altium, Allegro, OrCAD, or similar)
• High-speed design and grounding/shielding techniques
• Embedded systems experience (microcontrollers, firmware integration)
• Communication protocols (I2C, SPI, UART, CAN, BLE)
• Risk management and documentation (FMEA, design history files)
• Hands-on testing and troubleshooting with lab equipment
• Ability to develop test plans and execute verification protocols

Additional skills and experience that would be beneficial:

• Wireless connectivity (Bluetooth, Wi-Fi)
• Cybersecurity for connected medical devices
• Battery management systems and charging circuits
• DC/DC converters and power optimization
• FPGA or ASIC design exposure
• Basic Python or MATLAB for data analysis
• Familiarity with RTOS for embedded systems
• Understanding of IEC 62366 usability engineering
• Experience with Class II or III medical devices

Join us in San Diego, where you can contribute to cutting-edge medical device development in a city known for its beautiful beaches, thriving technology scene, and high quality of life.