Sr. Systems Engineer

As a key member of our Systems Engineering team, the Senior Systems Engineer will collaborate closely with R&D engineers, Clinical, QA and manufacturing engineering in all phases of medical device development, from early concept through qualification, field testing, and clinical use. 

• We are seeking an experienced Senior Systems Engineer to support the development of advanced medical device technologies from concept through commercialization. As a key member of the Systems Engineering team, this role will collaborate closely with Research & Development, Clinical, Quality, Manufacturing, Software, Electrical, Firmware, and Mechanical Engineering teams to ensure successful product development and system integration.
• The ideal candidate will have a strong background in systems engineering within a regulated medical device environment and experience translating clinical and business needs into engineering requirements, managing system-level risks, and leading verification and validation activities. This role requires a highly collaborative and self-directed engineer capable of leading multiple projects while ensuring the delivery of safe, effective, and high-quality products.

Required Qualifications

• Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related engineering discipline.
• Strong understanding of systems engineering principles and multidisciplinary product development.
• Experience developing system requirements, specifications, and engineering documentation.
• Experience performing verification and validation activities within a regulated environment.
• Knowledge of risk management methodologies and system-level hazard analysis.
• Proficiency with laboratory test equipment and measurement tools.
• Strong analytical, problem-solving, and troubleshooting skills.