Ventilator/ Respiratory Systems Principal Controls Engineer

The Principal System Algorithms & Controls Engineer leads and provides expertise in the development, characterization and testing of control software and hardware in medical devices. They develop complex hardware and systems that include high-voltage and pneumatic controls, motor control, sensors and pump drivers, plasma generation, optimize hardware and system performance, and troubleshoot hardware and system issues. They develop software/firmware algorithms that optimize the therapy delivery, gas flow delivery control, Nitric oxide generation, and pneumatic control for overall hardware and system operation. They formulate rational, data-driven decisions while designing software algorithms and complex electromechanical systems that meet medical product requirements. Develop and validate test methods that ensure compliance with requirements.

Responsibilities:

• Architect electro-mechanical subsystems and pneumatic for Nitric oxide generation, gas delivery control, and safety control.
• Understand analog and digital circuits for a complex system that generates nitric oxide gas, controls gas delivery, includes high voltage generation, current sensors, pneumatic control, environmental sensors, and gas delivery mechanisms
• Generates and implements software/firmware algorithms in C language including PID control loops for embedded software control and monitoring of complex systems, therapy delivery control, Nitric Oxide generation, and pneumatics
• Utilizes technical expertise to contribute to the development of system architectures for respiratory devices. Uses modeling, hardware-in-the-loop simulation and actual devices to develop, debug and test complex systems to meet required performance
• Develops and models complex cross-functional systems
• Performs advanced risk analyses using FMEA and fault tree methods. Works with other engineering disciplines to develop, implement, and verify system solutions
• Evaluates product performance on an on-going basis and initiates and evaluates required changes to the design to improve and optimize performance
• Interfaces with internal and external clinicians, physicians and thought leaders to create innovative products and features
• Ensures adherence to company quality system, product specifications, industry standards, and quality and regulatory procedures and requirements
• Maintains accurate documentation of concepts, designs, drawings, and processes through lab notebooks or other methods

Requirements:

• Master’s degree in electrical or computer engineering or related specialization, and 10+ years of related experience
• Experience with ventilators and/or respiratory applications
• Demonstrated experience designing, implementing, tuning and analyzing high accuracy, multi-sensor control circuits and systems, including high-performance PID feedback and open-loop controls
• Experience implementing software/firmware control algorithms in C language on embedded, real-time systems
• Experience with digital and analog electrical circuits
• Proven ability to engage effectively in risk analysis including FMEA
• Demonstrated strength in judgment, decision making, and critical thinking
• Excellent written and verbal communication
• Demonstrated strength in building relationships at all levels of an organization

Preferred Experience:

• ·PhD. in Electrical or computer engineering or related specialization
• Experience in software-based electromechanical medical device development
• Experience with statistical process control
• Experience with pneumatic systems and related components, particularly flow controllers
• Experience with Python, Jupyter, and data acquisition systems
• Experience performing design of experiments
• ISO 14971, IEC 60601, IEC 62304.
• Well-versed in medical product R&D and clinical/regulatory process

Third Pole, Inc. provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.