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Job Description
Structured overview of role & requirementsAbout This Role
Develop and verify model-based designs using MATLAB in collaboration with hardware and software teams to accelerate medical device product development.
Define and manage customer needs, regulatory requirements, and technical specifications from conception through product life cycle.
Lead risk management, usability engineering, and cross-functional collaboration to ensure compliance, safety, and successful integration of medical devices.
Minimum Requirements
Bachelor's degree with 6+ years or Master's degree with 3+ years in Biomedical, Electrical, Electronics, Software Engineering, Computer Science, Mechanical, Industrial Engineering or related.
Hands-on experience in system engineering for medical devices including MATLAB system modeling.
Knowledge of FDA regulations, Medical Device Regulation (MDR), usability engineering, and relevant standards (ISO, IEC).
Work Experience Required: 3+ years (Master's) or 6+ years (Bachelor's)
Ideal Candidate Profile
Experienced in medical device system engineering with strong model-based design skills using MATLAB.
Familiar with regulatory compliance processes and risk management in medical device development.
Capable of independently managing multiple projects and collaborating across R&D, verification, and validation teams.