K
Katalyst CRO
Systems Engineer
Skills
MATLABComplianceRisk Management
1 month ago
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Important information
Contract type:
Freelance / Contract
Location:
Dublin, CA 94568, USA
Work mode:
Onsite
Published on:
16 September 2026
What they need
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.
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