InnoTECH Staffing is looking to hire a Principal Algorithm & Controls Electrical Engineer for a well funded late stage medical device start-up in Waltham, MA.

The Principal 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, 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 electrical subsystems for Nitric oxide generation, gas delivery control, and safety control.
• Develop 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
• 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 ventilators and/or respiratory applications
• 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