Principal Embedded Software Engineer

The Principal Embedded Software Engineer leads and provides expertise in the

development, characterization, and testing of embedded software in medical devices in

terms of therapy delivery, system performance and cybersecurity. They interface

software with complex hardware and systems that include blowers, motor controllers,

proportional solenoids, solenoids, O2 sensors, pressure sensors, LCD screens, Wi-Fi,

Bluetooth, automatic software download to multiple processors, software authentication

and cybersecurity etc. They optimize system performance and troubleshoot hardware

and system issues. They develop software/firmware algorithms that optimize system

operation. They formulate rational, data-driven decisions while designing software

algorithms and complex electromechanical systems that meet medical product

requirements within the quality systems framework of ISO13485, IEC62304 and

ISO14971.

Essential Duties and Responsibilities:

• Architect software subsystems for software download, communication interfaces, user interface, control, and monitoring functions.
• Generates and implements software/firmware algorithms in C/ C++ language for embedded software control and monitoring of complex systems, therapy delivery control and pneumatics.
• Utilizes technical expertise to contribute to the development of system architectures for respiratory devices. Debug and test complex systems to meet required performance.
• Develop firmware and embedded software for connected products.
• 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 medical documentation practices.
• Mentor and learn from other team engineers.
• Participate in interviewing and onboarding new team members.

Knowledge and Skill Requirements:

• Desire and curiosity to learn new things.
• Degree in electrical, mechanical or computer engineering or related specialization, and 10+ years of related experience.
• Excellent written and verbal communication.
• Demonstrated experience designing, implementing embedded medical device software, writing interfaces to devices using serial, I2C, SPI, I2S, Bluetooth, Wi-Fi
• Experience implementing software/firmware algorithms in C language on embedded, real-time systems.
• Proven ability to engage effectively in risk analysis including FMEA (dFMEA and sFMEA).
• Demonstrated strength in judgment, decision making, and critical thinking in architectural software design, debugging software / hardware interfaces etc.
• Demonstrated strength in building relationships at all levels of an organization.

Preferred Experience:

• Electrical or computer engineering or related specialization.
• Experience in software-based electromechanical medical device development.
• Experience with embedded RTOS and bare-metal development for microcontroller
• Experience in developing automatic software updates across multiple processors in a single device maintain cybersecurity.
• Experience with pneumatic systems, blowers, motor control, flow sensors, pressure sensors and related components.
• Experience with ventilators and/or respiratory applications.
• Experience with Python, Matlab / Simulink, and data acquisition systems
• Working knowledge of ISO 14971, IEC 60601, IEC 62304 requirements as they pertain to software development.
• Well-versed in medical product R&D and clinical/regulatory process.

Training will be provided for ISO 13485:2016, Medical Device Directives (MDD’s)

93/42/EEC, applicable Regulation (EU) 2017/745 Medical Device Regulations and FDA

Quality System Regulations (QSR) 21 CFR 820 as applicable for job function.

This job description is intended to describe the general nature and level of work being

performed by employees assigned to this position. It is not intended to be a complete

list of all activities, tasks and skills required of employees in this position.