Position Overview: As a Senior Principal Systems Engineer, you will be a key technical leader in the development of complex medical devices, driving system architecture and design throughout the product lifecycle. You will collaborate with multidisciplinary teams across software, electrical, and mechanical to ensure seamless integration of various components, while also mentoring junior engineers to foster a culture of excellence and innovation.
Key Responsibilities:
- Lead the systems engineering efforts for complex Class II and Class III medical devices, ensuring alignment with regulatory requirements and industry best practices.
- Collaborate with cross-functional teams, including electrical, mechanical, software, and biomedical engineers, to develop robust system architectures and design specifications.
- Utilize MATLAB for mathematical modeling, signal processing, and analysis of system performance.
- Design and implement wireless communication solutions for medical devices, ensuring reliability and security in data transmission.
- Conduct requirements analysis, verification, and validation activities to ensure that system designs meet user needs and regulatory standards.
- Mentor and guide junior engineers in systems engineering practices and methodologies, promoting professional growth and development.
- Stay abreast of industry trends, emerging technologies, and best practices in systems engineering, medical device design, and cybersecurity.
- Support risk management activities, including hazard analysis and failure mode effects analysis (FMEA).
Qualifications:
- Bachelor's degree in Engineering (Electrical, Mechanical, Biomedical, Software, Optical, Computer Science, Physics); advanced degree preferred.
- Minimum of 10 years of experience in systems engineering, particularly in the development of complex Class II or Class III medical devices.
- Strong proficiency in MATLAB for modeling and signal processing.
- Experience with wireless communication protocols and systems.
- Familiarity with sensors and their integration into medical devices.
- Knowledge of mathematical modeling techniques to support system analysis and design.
- Cybersecurity experience is a plus but not required.
- Excellent problem-solving and analytical skills, with a strong attention to detail.
- Outstanding communication skills, with the ability to convey complex technical concepts to diverse audiences.