Job Description

A top medical device client is seeking a highly experienced, direct hire Principal Control Systems Engineer to lead the design and development of advanced control algorithms for life-saving and life-enhancing medical technologies in Irvine, CA. This is a senior-level role within our R&D Algorithm Development team, requiring deep expertise in control theory, signal processing, physiological systems, and algorithm development for medical device innovation.

This is a critical role in shaping the future of intelligent, closed-loop medical systems that improve patient outcomes through precision, automation, and real-time responsiveness.

Key Responsibilities:

• Apply control engineering, scientific, mathematical, signal processing, and human physiology experience to develop algorithms for critical care patient monitoring and drug delivery products, with specific focus on system automation and closed-loop control.
• Lead the design and implementation of control algorithms for medical devices, including closed-loop systems, adaptive control, and model predictive control.
• Develop simulation models (e.g., MATLAB/Simulink) to validate control strategies and optimize system performance.
• Analyze physiological signals and sensor data to inform algorithm design and improve device responsiveness.
• Lead research and feasibility of new concepts, conduct animal studies and clinical data collection, analyze and interpret clinical data, draw conclusions and prepare final reports and presentations.
• Conduct verification and validation testing in accordance with FDA and ISO standards.
• Support regulatory submissions by documenting algorithm design, performance, and safety considerations.
• Guide and mentor engineers on new and emerging technologies and projects.

Requirements:

• A bachelor’s degree in an Engineering or Scientific field with a minimum of 12 years of experience is required.
• Or a master’s degree in an Engineering or Scientific field with a minimum of 11 years of experience is required.
• Or a PhD or equivalent in an Engineering or Scientific field with a minimum of 8 years of experience is required. PhD highly preferred.
• Recognized as an expert within the field of Control Engineering.
• Expert knowledge and understanding of principles, theories, and concepts of control engineering and system dynamics.
• Expert knowledge in signal processing, system identification, mathematical modeling and algorithm development.
• Demonstrated proficiency in design, optimization, and validation of control systems and algorithms.
• Strong experience with real-time signals, systems and sensors integration.
• Proficiency in MATLAB/Simulink and C/C++ for embedded systems. Real-time implementation and integration of control algorithms.
• Strong background in human physiology and anatomy with specific knowledge of cardiovascular hemodynamics and vital signs parameters. Experience with physiological waveforms and parameters.
• Experience in modeling of the pharmacokinetics and dynamics of drugs.
• Experience with design and implementation of physiologic closed-loop controlled medical devices, such as insulin delivery systems, mechanical ventilators and anesthesia delivery systems.
• Experience with FDA design controls and IEC software lifecycle processes.
• Knowledge of machine learning and AI techniques applied to control systems.
• Requires a high-energy individual who has excellent teamwork, partnering, and negotiation skills.
• Strong communication skills are needed to facilitate working with BD teams and executives, third parties, physician collaborators and principal investigators.

Salary of $200,000 to $250,000 annually + bonus and stock options

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