Systems Engineer

Job Requirements We are seeking a highly skilled and motivated Technical Lead Systems Engineer to join our dynamic team. The successful candidate will lead the design, development, and integration of complex Medical devices and sub systems. This role requires a deep understanding of both the technical and regulatory aspects of medical device development. Key Responsibilities Lead the systems engineering efforts for product development, from concept through commercialization for medical devices Develop and manage system requirements, architecture, and design documentation. Oversee the integration of hardware, software, and assay components into cohesive systems. Defines User Requirements, system requirements, FMEA, architecture, and interfaces to meet product requirements, risk analysis and industry standards; conducts system design analysis to select key components and defines control methods; and coordinates build and design integration. Conducts design reviews as part of the product development process to ensure customer requirements are met and the designs are manufacture-able, serviceable, and reliable. In addition, it does the same for subsystem requirements and product integration. Collaborate with cross-functional teams, including regulatory, Bio Compatibility, software, and hardware engineering, to ensure seamless product development. Conduct risk assessments and develop mitigation strategies. Ensure compliance with relevant regulatory standards, including ISO 13485 and FDA 21 CFR Part 820. Provide technical leadership and mentorship to junior engineers. Stay up-to-date with advancements in Medical Device technologies and regulatory changes. Qualifications Work Experience Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, or related field. 5-8 years of experience in systems engineering, with at least 3 years in medical device product development / Sustaining Engineering. Strong background in medical device risk management process in compliance with ISO 14971. Hands on experience in developing risk management documents (RMP, RMM, RMR Risk Benefit Analysis, DFMEA/PFMEA/UFMEA). Strong understanding of medical device development processes, including design control, risk management, and regulatory requirements. Strong analytical and problem-solving abilities. Effective communication skills, both written and verbal. Show more Show less