Job Title: Medical Device Controls Engineer

Job Summary:

The Mid-Level Medical Device Controls Engineer is responsible for designing, developing, and optimizing control systems for medical devices. This role involves handling complex technical challenges, leading system testing and validation efforts, and ensuring compliance with regulatory standards. The engineer works collaboratively with cross-functional teams and contributes to improving device reliability, performance, and safety.

Key Responsibilities:

Control System Design and Development:

• Design and implement advanced control algorithms for medical devices, ensuring precision and reliability.
• Integrate sensors, actuators, and embedded systems to enhance device performance.
• Optimize control logic using programming languages such as C, C++, or Python to meet design requirements.

System Testing and Validation:

• Lead functional, performance, and safety testing of control systems to meet regulatory and design specifications.
• Develop validation protocols and oversee testing processes to ensure compliance with FDA and ISO standards.
• Document test results, troubleshoot issues, and implement corrective measures.

Troubleshooting and Optimization:

• Diagnose and resolve complex technical issues in control systems using advanced diagnostic tools.
• Perform root cause analysis for recurring problems and implement solutions to enhance system reliability.
• Collaborate with hardware and software teams to refine system performance.

Regulatory Compliance and Quality Assurance:

• Ensure all control systems comply with medical device regulatory standards, including FDA, ISO 13485, and IEC 60601.
• Prepare and maintain technical documentation for audits, submissions, and internal reviews.
• Support internal and external audits to ensure adherence to compliance requirements.

Project Management and Collaboration:

• Manage medium-scale projects, including timelines, resource allocation, and deliverables.
• Collaborate with cross-functional teams, including hardware, software, and quality assurance, to ensure seamless system integration.
• Work closely with vendors and external partners to source components and address technical challenges.

Mentorship and Team Support:

• Provide technical guidance and support to junior engineers and team members.
• Conduct training sessions to enhance team knowledge of control systems and regulatory requirements.

Innovation and Continuous Improvement:

• Research and implement emerging technologies, such as AI and IoT, in medical device controls.
• Identify opportunities for workflow optimization and system enhancements.
• Contribute to the development of innovative solutions for next-generation medical devices.

Key Focus Areas:

• Control System Leadership: Lead the design, development, and optimization of control systems.
• Testing and Validation: Manage testing processes to ensure compliance with safety and performance standards.
• Troubleshooting: Address complex technical challenges to enhance system reliability.
• Collaboration and Mentorship: Work with teams to ensure integration and provide guidance to junior staff.

Skills and Knowledge Required:

• Advanced understanding of control systems, including feedback loops, PID controllers, and real-time systems.
• Proficiency in programming languages such as C, C++, Python, or MATLAB for control system development.
• Experience with embedded systems and microcontrollers (e.g., ARM Cortex, STM32).
• Strong knowledge of regulatory standards, including FDA, ISO 13485, and IEC 60601.
• Analytical and problem-solving skills for diagnosing and optimizing control systems.

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 (e.g., ISO 13485, Lean Six Sigma) are preferred.

Experience:

• 3-5 years of experience in designing, developing, and maintaining control systems for medical devices or related industries.

Tools and Technologies:

• Expertise in control system development platforms, such as MATLAB/Simulink.
• Proficiency in diagnostic and debugging tools, including oscilloscopes, logic analyzers, and signal generators.
• Familiarity with version control systems (e.g., Git) and embedded debugging tools.
• Exposure to AI, IoT, or machine learning applications in medical device controls is advantageous.

Other Requirements:

• Strong organizational and multitasking skills to manage multiple projects effectively.
• Ability to work collaboratively with cross-functional teams and communicate technical concepts clearly.
• Commitment to maintaining quality, safety, and compliance standards in all activities.