Principal Controls Engineer
Direct Hire Position
The Principal Controls Engineer provides expertise in the development, characterization and testing of control software and hardware in medical devices. They develop complex systems that include high-voltage and pneumatic controls, optimize system performance, and troubleshoot system issues. They formulate rational, data-driven decisions while designing software algorithms and complex electromechanical systems that meet product requirements. Develop and validate test methods that ensure compliance with requirements.
Responsibilities: • Develops and models complex cross-functional systems • Generates algorithms including PID control loops for embedded software control and monitoring of complex systems and phenomena • Utilizes technical expertise to develop 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 • 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
Demonstrated experience designing, implementing, tuning and analyzing high accuracy, multi-sensor control systems, including high-performance feedback control in software • Experience implementing and tuning high-performance feedback control in software • Experience with digital AC/DC and DC/DC power conversion • Bachelors degree in engineering or related specialization, and 8+ years of related experience • 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: • Masters and/or Ph.D. degree in 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