Systems Engineer

Katalyst CRO; Dublin (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO in California is seeking a Senior Systems Engineer to lead design and integration of medical device products across hardware, software, mechanical, and electrical domains. The role requires hands-on control systems experience, familiarity with FDA/IEC standards, and collaboration with cross-functional teams to deliver reliable, compliant systems from prototype to production.

On-site work in the USA is required; strong debugging, reading schematics, and risk management skills are

Qualifications

• Bachelor's or master's degree in systems engineering or electrical engineering.
• Experience as a Systems Engineer in medical device development across full product lifecycle.
• Knowledge of analog/digital electronics, sensors, motors, actuators, and embedded platforms.
• Hands-on control systems design, modeling, tuning (PID and advanced control), real-time implementation.
• Experience with XYZ mechanical motion systems, precision positioning, robotics, or multi-axis motion control.
• Experience integrating software, mechanical, and electrical subsystems into cohesive products.
• Familiarity with FDA, IEC 60601, ISO 13485, ISO 14971.
• Ability to read mechanical drawings, electrical schematics, and system block diagrams.
• Strong debugging, problem-solving, and root-cause analysis skills.
• Excellent communication and collaboration skills.
• Willingness and ability to work onsite in the USA.

Responsibilities

• Lead system-level design and integration of medical device products across hardware, software, mechanical, and electrical domains.
• Design and review hardware architectures including sensors, actuators, controllers, and embedded subsystems.
• Develop and validate control systems for precise multi-axis motion and closed-loop feedback.
• Collaborate with mechanical engineers to validate kinematic designs and tolerances.
• Coordinate with software teams for embedded and application-level integration.
• Drive requirements definition, allocation, traceability, and verification.
• Engage in risk management (FMEA) and ensure regulatory compliance.
• Support prototyping, system integration, and testing.
• Interface with manufacturing, quality, and regulatory teams for design transfer.
• Provide on-site technical support and continuous improvement for deployed systems.

Skills

Systems engineering

Control systems design

Embedded platforms

PID tuning

Diagnostics & debugging

Cross-functional collaboration

Reading schematics

Regulatory awareness

Education

Bachelor's or Master's in Systems Engineering or Electrical Engineering

Tools

MATLAB/Simulink

LabVIEW

Motion controllers

Job description

Responsibilities

• Lead system-level design, development, and integration of medical device products across hardware, software, mechanical, and electrical domains.
• Design and review hardware architectures, including sensors, actuators, controllers, and embedded subsystems.
• Develop and validate control systems for precise XYZ multi axis mechanical motion, motion profiling, and closed-loop feedback systems.
• Collaborate with mechanical engineers to define and validate kinematic designs, tolerances, and movement accuracy for complex electromechanical systems.
• Work closely with software teams on embedded and application-level software integration, ensuring seamless interaction with hardware and control systems.
• Drive system requirements definition, allocation, traceability, and verification throughout the product lifecycle.
• Participate in risk management activities (FMEA, fault analysis) and ensure compliance with medical device standards and regulatory requirements.
• Support prototyping, system integration, debugging, verification, and validation testing at component and system levels.
• Interface with manufacturing, quality, and regulatory teams to support design transfer and product commercialization.
• Provide on-site technical support, issue resolution, and continuous improvement for deployed systems.

Requirements And Skills

• Bachelor's or master's degree in systems Engineering or Electrical Engineering
• Proven experience as a Systems Engineer in medical device development, including full product lifecycle involvement.
• Knowledge of Systems design, including analog/digital electronics, sensors, motors, actuators, and embedded platforms.
• Hands-on experience with control systems design, modeling, tuning (PID and advanced control), and real-time implementation.
• Demonstrated expertise in XYZ mechanical motion systems, precision positioning, robotics, or multi-axis motion control.
• Experience integrating software, mechanical, and electrical subsystems into cohesive, reliable products.
• Familiarity with medical device regulations and standards (e.g., FDA, IEC 60601, ISO 13485, ISO 14971).
• Ability to read and interpret mechanical drawings, electrical schematics, and system block diagrams.
• Strong debugging, problem-solving, and root-cause analysis skills in complex electromechanical systems.
• Excellent communication and collaboration skills, with the ability to work effectively on cross-functional teams.
• Willingness and ability to work onsite in the USA.

Good To Have

• Experience with MATLAB/Simulink for system modeling, control design, and simulation.
• Hands on experience using LabVIEW for test automation, system validation, and data acquisition.
• Practical experience with motion controllers (commercial or custom) used in precision positioning systems.

Qualification

• B.E / M.S / MTech.