Job Title: Medical Device Controls Engineer

Job Summary:

The Senior Medical Device Controls Engineer is responsible for leading the design, development, and optimization of advanced control systems for medical devices. This role involves managing large-scale projects, resolving complex technical challenges, and ensuring full compliance with industry standards and regulations. The senior engineer provides mentorship to team members, drives innovation, and collaborates with cross-functional teams to ensure device reliability, safety, and efficiency.

Key Responsibilities:

Control System Design and Development:

• Lead the design and implementation of advanced control algorithms for medical devices, ensuring precision, efficiency, and reliability.
• Oversee the integration of sensors, actuators, and embedded systems into control architectures.
• Optimize control systems through advanced programming (C, C++, Python, MATLAB) and system modeling techniques.

System Testing and Validation:

• Define and execute comprehensive validation protocols for control systems to ensure compliance with regulatory standards.
• Lead functional and performance testing of control systems to verify design specifications and safety requirements.
• Analyze test data to identify areas for improvement and implement solutions to enhance device performance.

Troubleshooting and Optimization:

• Resolve complex technical challenges related to control system performance and reliability.
• Conduct root cause analyses for system failures and implement corrective and preventive actions.
• Collaborate with hardware and software teams to address multidisciplinary technical challenges.

Regulatory Compliance and Quality Assurance:

• Ensure all control systems comply with industry standards such as FDA, ISO 13485, and IEC 60601.
• Prepare detailed documentation for regulatory submissions, audits, and internal reviews.
• Lead internal and external audits to maintain compliance and quality certifications.

Project Management:

• Manage large-scale projects, from conceptualization to deployment, ensuring timelines and budgets are met.
• Coordinate with cross-functional teams to align project objectives with organizational goals.
• Report project progress, risks, and outcomes to senior leadership and stakeholders.

Mentorship and Leadership:

• Provide technical guidance and mentorship to junior and mid-level engineers.
• Lead training programs to enhance team expertise in control systems and compliance standards.
• Supervise the work of team members to ensure alignment with project and organizational goals.

Innovation and Continuous Improvement:

• Research and implement emerging technologies such as AI, IoT, and machine learning in control systems.
• Propose and drive initiatives to improve workflow efficiency and device performance.
• Contribute to the development of innovative solutions for next-generation medical devices.

Key Focus Areas:

• Leadership in Control Systems: Drive the development and optimization of control systems for advanced medical devices.
• Regulatory Compliance: Ensure all systems adhere to industry standards and regulatory requirements.
• Project Oversight: Lead and manage large-scale control system projects to successful completion.
• Mentorship and Innovation: Guide team members and foster innovation in device design and functionality.

Skills and Knowledge Required:

• Expert knowledge of control systems, including feedback loops, real-time systems, and PID controllers.
• Proficiency in programming languages such as C, C++, Python, and MATLAB/Simulink.
• In-depth understanding of embedded systems and microcontroller programming (e.g., ARM Cortex, STM32).
• Comprehensive knowledge of regulatory standards (FDA, ISO 13485, IEC 60601) and quality management systems.
• Strong analytical and problem-solving skills for addressing complex technical challenges.

Educational Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Control Systems Engineering, Electronics Engineering, or a related technical field.
• Advanced certifications in medical device design, quality management (e.g., ISO 13485, Lean Six Sigma), or project management (e.g., PMP) are highly desirable.

Experience:

• 7-10 years of experience in designing, developing, and maintaining control systems for medical devices or related industries.
• Proven track record of leading multidisciplinary teams and managing large-scale projects.

Tools and Technologies:

• Expertise in control system development platforms such as MATLAB/Simulink and LabVIEW.
• Proficiency with diagnostic and debugging tools (e.g., oscilloscopes, logic analyzers, signal generators).
• Familiarity with AI, IoT, and machine learning technologies for advanced control systems.
• Knowledge of project management tools (e.g., MS Project, Primavera).

Other Requirements:

• Exceptional leadership and organizational skills to manage complex projects and teams effectively.
• Strong communication and interpersonal skills to interact with stakeholders and cross-functional teams.
• Willingness to travel occasionally for project oversight and training.
• Commitment to maintaining safety, quality, and compliance in all activities.