Job Title: Medical Device Controls Engineer

Job Summary:

The Manager-Level Medical Device Controls Engineer is responsible for leading the strategy, development, and oversight of control systems for medical devices. This role involves managing teams, overseeing project execution, and ensuring compliance with regulatory standards. The manager drives innovation, fosters collaboration, and aligns control system development with organizational goals to ensure device safety, reliability, and efficiency.

Key Responsibilities:

Strategic Planning and Leadership:

• Develop and implement strategies for the design, development, and maintenance of advanced control systems for medical devices.
• Define objectives, allocate resources, and set performance metrics to achieve project goals and organizational objectives.
• Monitor and analyze control system performance metrics to identify areas for improvement and innovation.

System Oversight and Optimization:

• Oversee the design, integration, and testing of complex control systems, including sensors, actuators, and embedded software.
• Ensure the implementation of advanced algorithms to optimize device performance and reliability.
• Evaluate and adopt emerging technologies, such as AI and IoT, to enhance control system capabilities.

Regulatory Compliance and Quality Assurance:

• Ensure all control system activities comply with regulatory standards, including FDA, ISO 13485, and IEC 60601.
• Lead internal and external audits to maintain compliance certifications and address regulatory requirements.
• Develop and enforce standard operating procedures (SOPs) for control system design, testing, and documentation.

Team Management and Development:

• Manage and mentor a multidisciplinary team of engineers, fostering a culture of collaboration and innovation.
• Conduct performance evaluations, provide feedback, and identify training needs to enhance team capabilities.
• Ensure team alignment with regulatory standards and organizational goals through regular communication and guidance.

Project Management:

• Lead large-scale projects involving control system development, testing, and deployment, ensuring timelines and budgets are met.
• Coordinate with cross-functional teams, including hardware, software, and quality assurance, to ensure seamless integration.
• Report project progress, risks, and outcomes to senior leadership and stakeholders.

Stakeholder Engagement and Communication:

• Act as a primary liaison between internal teams, regulatory bodies, and external stakeholders to align control system solutions with organizational objectives.
• Provide regular updates on system performance, compliance metrics, and project progress to stakeholders.
• Address operational challenges and implement solutions to improve system reliability and user satisfaction.

Innovation and Continuous Improvement:

• Drive innovation by researching and implementing emerging technologies in control system development.
• Propose and lead initiatives to improve workflow efficiency, reduce costs, and enhance device performance.
• Stay updated on industry trends and regulatory changes to inform strategic planning and system upgrades.

Key Focus Areas:

• Strategic Leadership: Oversee the development and optimization of control systems in alignment with organizational goals.
• Compliance Management: Ensure adherence to regulatory standards and maintain audit readiness.
• Team Leadership: Build and manage high-performing technical teams, fostering innovation and collaboration.
• Project Execution: Lead large-scale projects, ensuring successful delivery within budget and timelines.

Skills and Knowledge Required:

• Comprehensive knowledge of control systems, including feedback loops, real-time systems, and PID controllers.
• Proficiency in programming languages (C, C++, Python, MATLAB) and familiarity with embedded systems.
• Expertise in regulatory compliance standards (FDA, ISO 13485, IEC 60601) and quality management systems.
• Advanced project management skills, including resource planning, budgeting, and risk management.
• Leadership and organizational skills to manage multidisciplinary teams and drive operational excellence.

Educational Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Control Systems Engineering, Electronics Engineering, or a related technical field.
• Advanced certifications in project management (e.g., PMP, PRINCE2), quality systems (e.g., ISO 13485), or control systems are highly desirable.

Experience:

• 10+ years of experience in designing, developing, and managing control systems for medical devices or related industries.
• At least 3-5 years of experience in a leadership role managing teams and large-scale projects.

Tools and Technologies:

• Proficiency with control system platforms, such as MATLAB/Simulink and LabVIEW.
• Familiarity with diagnostic tools and debugging equipment (e.g., oscilloscopes, logic analyzers).
• Expertise in data analytics and predictive maintenance tools for system performance optimization.
• Knowledge of project management software (e.g., MS Project, Primavera).

Other Requirements:

• Exceptional decision-making and organizational skills to manage complex projects effectively.
• Strong communication and interpersonal skills to collaborate with teams and engage with stakeholders.
• Willingness to travel occasionally for project oversight, audits, or training sessions.
• Commitment to maintaining safety, quality, and compliance in all control system activities.