Systems Engineer

Creative Solutions Services, LLC; Dublin (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Systems Engineer to lead system‑level design, development, and integration of medical device products spanning hardware, software, mechanical, and electrical domains.

You will design and review hardware architectures, develop and validate control systems, and collaborate across teams to ensure regulatory compliance and successful design transfer from prototyping to commercialization.

Qualifications

• Bachelor's or Master's degree in systems or electrical engineering.
• Experience as Systems Engineer in medical device development across full product lifecycle.
• Knowledge of analog/digital electronics, sensors, motors, actuators, and embedded platforms.
• Experience with control systems design, modeling, tuning, and real-time implementation.
• Familiarity with medical device regulations (FDA, IEC 60601, ISO 13485, ISO 14971).
• Ability to read mechanical drawings and electrical schematics.

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.
• 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.

Skills

Systems design

Control systems design

Embedded systems experience

Cross-functional collaboration

Reading schematics & drawings

Root-cause analysis

Debugging complex systems

Education

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

Tools

MATLAB/Simulink

LabVIEW

CAD tools

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.