Job Duties:

The Principal Systems Engineer will be responsible for designing, implementing, and validation of complex medical devices and systems, working across interdisciplinary teams to ensure system functionality, safety, and compliance with industry standards. This role involves driving complex system-level solutions from concept to production, integrating hardware, software, and mechanical components into robust and reliable medical devices. The Principal Systems Engineer will collaborate across various teams, manage system requirements, and ensure product quality, safety, and performance. The Principal Systems Engineer will perform the following duties:

Responsible for coordinating with functional and cross functional team members to ensure project milestones are achieved.
Lead the development of control algorithms, signal processing, and system modeling for medical devices, ensuring precise, reliable, and safe operation.
Develop control systems for key device functions (PID controllers) to ensure system stability and performance.
Responsible for leading integrated control systems with embedded hardware and software, ensuring seamless interaction between electronic components, sensors, and actuators.
Responsible for strategizing and development of integration test plans to ensure product requirements specifications are met. Coordinate integration testing activities with internal teams and external partners to ensure V&V testing deliverables are met.
Oversee and conduct a wide range of tests, including functional, performance, reliability, and environmental tests on complex medical device systems (e.g. 60601-1, 60601-1-2, HALT).
Lead investigations into complex technical issues or failures related to hardware/software sub-components. Apply advanced problem-solving techniques, such as root cause analysis (RCA) and failure mode and effects analysis (FMEA), to identify underlying causes and implement robust corrective actions.
Diagnose and troubleshoot complex hardware issues, working collaboratively with cross-functional teams to implement solutions.
Utilize tools such as MATLAB, Simulink, or LabVIEW to model and optimize control systems, verifying algorithms before deployment in physical systems.
Share knowledge, best practices, and lessons learned from previous experiences to cultivate a culture of learning and excellence within the engineering team.

Job Requirements:

Bachelor’s degree (or foreign equivalent) in Bioengineering, Mechanical Engineering, Electrical Engineering, Software Engineering, or related technical field and 5 years of experience in systems engineering, system architecture design and control system design, and/or related field, preferably in medical devices or MS degree (or foreign equivalent) in Bioengineering, Mechanical Engineering, Electrical Engineering, Software Engineering, or related technical field and 2 years of experience in systems engineering, system architecture design and control system design, and/or related field, preferably in medical devices.

Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be quantified by time. Required expertise/knowledge includes:

Expert knowledge on medical device regulations and standards, including FDA QSR, ISO 13485, ISO 60601, ISO 14971, providing guidance on interpretation and implementation to ensure compliance.
Proven experience and mastery in conducting thorough analysis and evaluation of technical requirements, feasibility, and risks; and developing comprehensive engineering solutions and mitigation strategies for new product development.
Experience reviewing FDA regulatory submissions for medical devices
Proficiency in one or multiple scripting languages (such as MATLAB, Fortran, C++, Python, etc.)
Hands-on experience with testing with embedded systems, sensors, actuators, and hardware-software integration (including but not limited to flow and pressure sensors, pumps, motors, valves, etc.)
Proficiency in using test equipment such as oscilloscopes, multimeters, spectrum analyzers, and logic analyzers.
Working knowledge of various communication protocols: I2C, SPI, UART, CANBUS, and Ethernet.
Proficiency in control system development tools such as MATLAB, Simulink, or LabVIEW, or similar for automated testing environment design
Proficiency in algorithm development for control systems and alarms
Experience in performing system and subsystem-level characterization of electro-mechanical systems for designing control algorithms to meet system-level requirements.
Experience with risk management processes and developing risk management documentation (such as DFMEAs, System Hazard Analysis, etc.)
Exceptional problem-solving skills and the ability to conceptualize and develop innovative engineering solutions to investigate and solve complex technical challenges and mitigate system risks.

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