Principal Control Systems Scientist (R&D) / Medical Device

Irvine, California (100% Onsite with a required minimum in-office presence) Department: Research & Development / Algorithm Engineering Employment Type: Full-Time

200-250K+ Bonus + Paid Relocation 

Role Summary: Defining the Future of Closed-Loop Medical Technology

We are seeking a Principal Control Systems Scientist to drive the strategic development of advanced, life-saving control algorithms within our R&D organization. This is a top-tier individual contributor role requiring a recognized expert in control theory, applied mathematics, and human physiology to pioneer the next generation of intelligent, closed-loop medical devices.

The Principal Scientist will serve as the technical authority for complex control systems, directly influencing product architecture to ensure optimal precision, safety, and real-time responsiveness in critical care and drug delivery technologies. This role moves beyond standard engineering to focus on scientific modeling, hypothesis generation, and the mathematical rigor required for FDA-regulated systems.

Principal Roles and Scientific Leadership

The Principal Control Systems Scientist will be responsible for setting the scientific direction and ensuring the technical integrity of all control algorithms. Key responsibilities include:

• Scientific Leadership & Strategy: Act as the subject matter expert and technical lead for all closed-loop control system design within the R&D portfolio. Define the long-term algorithm roadmap and guide the research team on emergent control technologies.

• Advanced Model Development: Design, formulate, and validate complex mathematical and simulation models (MATLAB/Simulink) of human physiological systems (e.g., cardiovascular hemodynamics, pharmacokinetics/pharmacodynamics) to serve as the foundation for new control strategies.

• Algorithm Innovation: Lead the development and implementation of advanced control algorithms, including Model Predictive Control (MPC), adaptive control, and robust control strategies, to achieve precision automation in medical devices.

• Physiological Data Analysis: Apply advanced signal processing and statistical methods to analyze complex physiological waveforms and sensor data, translating raw measurements into actionable control parameters.

• Clinical and Feasibility Research: Design and lead the scientific execution of in-vitro, animal, and clinical feasibility studies to collect data, validate physiological models, and characterize algorithm performance under real-world conditions.

• Regulatory & Safety Rigor: Ensure all scientific models and algorithm designs meet the stringent requirements of FDA design controls and relevant safety standards (e.g., IEC 62304). Provide critical technical documentation and subject matter expertise for regulatory submissions.

• Technical Mentorship: Provide expert guidance and mentorship to other R&D engineers and scientists, promoting a culture of rigor, best practices, and innovation in control systems.

Required Qualifications and Scientific Experience

This is a senior scientific role requiring significant depth of knowledge and proven leadership in regulated environments.

• Education: PhD in Control Systems Engineering, Biomedical Engineering, Applied Mathematics, or a related scientific field is highly preferred, with a minimum of 8 years of relevant experience.

  • Alternative: Master’s degree with a minimum of 11 years of experience, or a Bachelor’s degree with a minimum of 12 years of experience.

• Core Expertise:

  • Expert recognition in control engineering principles, system identification, and system dynamics, specifically applied to biological or physiological systems.

  • Expert-level proficiency in designing, optimizing, and validating highly complex, real-time control algorithms.

  • Deep expertise in mathematical modeling, signal processing, and algorithm development in MATLAB/Simulink.

• Medical Device Focus:

  • Extensive experience with the modeling of pharmacokinetics and dynamics of common drugs.

  • Strong background in human physiology and anatomy, with specific experience modeling or controlling cardiovascular hemodynamics and vital sign parameters.

  • Direct experience with the design and implementation of physiologic closed-loop controlled medical devices (e.g., infusion pumps, ventilators).

• Implementation Skills: Proficiency in implementing and integrating control algorithms using C/C++ for embedded, real-time systems.

• Regulatory Knowledge: In-depth knowledge of FDA design controls and the software lifecycle processes required for medical device development.

Preferred Scientific Qualifications

• Experience applying Machine Learning or AI techniques to adaptive control systems or predictive modeling of physiological states.

• Experience leading cross-functional research teams through the full development lifecycle, from concept and modeling to clinical V&V.