Senior Manager, Controls Engineering
Seeking a highly experienced and strategic Senior Manager, Controls Engineering to lead a multidisciplinary team in the design, development, and implementation of advanced control systems for cutting-edge medical devices. This role is critical to ensuring our products meet the highest standards of performance, safety, and regulatory compliance.
Key Responsibilities:
Leadership & Strategy
- Lead and mentor a team of controls engineers, fostering a culture of innovation, collaboration, and continuous improvement.
- Develop and execute the controls engineering roadmap aligned with product development and business objectives.
- Collaborate cross-functionally with mechanical, electrical, software, and quality teams to ensure seamless integration of control systems.
Technical Oversight
- Oversee the design and implementation of control algorithms, embedded systems, and automation solutions for medical devices.
- Ensure robust system modeling, simulation, and validation using tools such as MATLAB/Simulink, LabVIEW, or equivalent.
- Drive architecture decisions for control systems, including sensor integration, actuator control, and feedback loops.
Project Management
- Manage multiple concurrent projects, ensuring timely delivery within scope and budget.
- Establish and monitor key performance indicators (KPIs) for controls engineering activities.
- Support risk management, design reviews, and regulatory submissions (e.g., FDA, ISO 13485).
Compliance & Quality
- Ensure all control systems meet applicable regulatory and safety standards.
- Maintain documentation and traceability in accordance with design control processes.
- Support audits and inspections related to controls engineering.
Qualifications:
- Bachelor's or Master's degree in Electrical Engineering, Mechanical Engineering, Mechatronics, or related field.
- 10+ years of experience in controls engineering, with at least 3-5 years in a leadership role.
- Proven experience in medical device development or other regulated industries.
- Strong knowledge of control theory, embedded systems, and automation technologies.
- Proficiency in tools such as MATLAB/Simulink, LabVIEW, C/C++, Python, and PLC programming.
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