Principal Control Systems Scientist; R&D​/Medical Device

Role

Summary:

Defining the Future of Closed-Loop Medical Technology

We are seeking aPrincipal Control Systems Scientistto 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 thetechnical authorityfor 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 onscientific modeling, hypothesis generation, and the mathematical rigorrequired for FDA-regulated systems.

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, includingModel 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 ofFDA design controlsand 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.

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

• Education:PhDin Control Systems Engineering, Biomedical Engineering, Applied Mathematics, or a related scientific field ishighly preferred, with a minimum of8 yearsof 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 recognitionin control engineering principles, system identification, and system dynamics, specifically applied to biological or physiological systems.

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

  • Deep expertise inmathematical modeling, signal processing, and algorithm development inMATLAB/Simulink.

• Medical Device Focus:

  • Extensive experience with themodeling of pharmacokinetics and dynamicsof common drugs.

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

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

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

• Regulatory Knowledge:In-depth knowledge ofFDA design controlsand the software lifecycle processes required for medical device development.

• Experience applyingMachine Learning or AI techniquesto 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.