Job Title: Medical Device Controls Engineer

Job Summary:

The Junior Medical Device Controls Engineer is responsible for assisting in the design, development, and validation of control systems for medical devices. This role involves handling routine tasks independently, troubleshooting control system issues, and supporting cross-functional teams to ensure devices meet performance and regulatory standards. The engineer works under minimal supervision and contributes to improving control algorithms and device reliability.

Key Responsibilities:

Control System Development:

• Develop and implement control algorithms for medical devices, ensuring accuracy, reliability, and compliance.
• Support the integration of sensors, actuators, and embedded systems within device control architectures.
• Write and optimize code for control systems using programming languages such as C, C++, or Python.

System Testing and Validation:

• Conduct functional and performance testing of control systems to ensure compliance with design specifications.
• Identify and troubleshoot issues during testing and propose corrective actions.
• Assist in developing and maintaining validation protocols and documentation for regulatory compliance.

Troubleshooting and Debugging:

• Diagnose and resolve technical issues in control systems during development and testing phases.
• Utilize diagnostic tools and methodologies to identify root causes and implement solutions.
• Collaborate with senior engineers to refine system performance and reliability.

Regulatory Compliance:

• Ensure control system designs comply with regulatory standards, including FDA, ISO 13485, and IEC 60601.
• Support internal and external audits by providing accurate documentation of control system operations.

Collaboration and Communication:

• Work closely with cross-functional teams, including hardware engineers, software developers, and quality assurance teams, to ensure seamless system integration.
• Provide technical support to manufacturing teams during production and testing phases.
• Contribute to technical documentation and reports for project reviews and compliance purposes.

Learning and Development:

• Enhance knowledge of advanced control systems, embedded technologies, and regulatory standards.
• Stay updated on emerging trends and best practices in medical device controls and automation.
• Participate in training sessions and workshops to build technical and regulatory expertise.

Key Focus Areas:

• Control Development: Design and test control systems to meet medical device performance requirements.
• Testing and Debugging: Perform system validation and troubleshoot issues to ensure reliability.
• Regulatory Adherence: Maintain compliance with medical device safety and regulatory standards.
• Collaboration: Coordinate with teams to integrate control systems into device workflows.

Skills and Knowledge Required:

• Solid understanding of control systems, including feedback loops, PID controllers, and sensor integration.
• Proficiency in programming languages such as C, C++, Python, or MATLAB.
• Knowledge of embedded systems and microcontrollers (e.g., ARM Cortex, Arduino, or STM32).
• Familiarity with regulatory standards for medical devices, such as FDA, ISO 13485, and IEC 60601.
• Strong analytical and problem-solving skills for system debugging and optimization.

Educational Qualifications:

• Bachelor’s degree in Biomedical Engineering, Control Systems Engineering, Electronics Engineering, or a related technical field.
• Certifications in control systems, embedded systems, or medical device development are advantageous.

Experience:

• 1-2 years of experience in developing and maintaining control systems, preferably for medical devices or related industries.

Tools and Technologies:

• Proficiency with tools for control system simulation and development (e.g., MATLAB/Simulink).
• Familiarity with diagnostic tools such as oscilloscopes, logic analyzers, and signal generators.
• Basic knowledge of version control systems (e.g., Git) and debugging tools for embedded systems.

Other Requirements:

• Ability to work independently on routine tasks and collaborate effectively with cross-functional teams.
• Strong organizational and documentation skills to maintain accurate records and compliance documentation.
• Commitment to upholding high standards of quality, safety, and regulatory compliance.