System Integrator – Medical Devices
2 weeks ago
At IF MedTech, we are dedicated to revolutionizing healthcare through cutting-edge medical device design, development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering, business, and research domains to bring innovative solutions that enhance healthcare and improve lives. Join us in our mission to drive innovation and make a global impact in the medical technology sector.Responsibilities: ● Define, refine, and maintain system architecture across multiple medical devices. ● Identify and document critical subsystems, their interdependencies, and system integration complexity. ● Create and maintain system block diagrams, interface control documents (ICDs), and control/data flow charts. ● Decompose product requirements into core working principles and coordinate engineering solutions around them. ● Ensure coherence in product function, behavior, and user experience. ● Conduct early design feasibility assessments to identify critical components that determine system feasibility ● Map critical development paths, including components with long lead times, dependency risks, and integration constraints. ● Proactively flag dependencies that can delay product readiness and escalate mitigation strategies. ● Lead the technical integration of mechanical, electronic, firmware, and industrial design subsystems. ● Coordinate to define tolerances, mounting constraints, connector selection, and interface sealing as per product use case. ● Lead system-level DFMEA/ PFMEA, including interface-level failure modes ● Collaborate with V&V to map requirements to test cases, ensuring test coverage for integrated systems. ● Actively support prototype building and test bench development and debug integration-related during testing. ● Own the integration readiness checklist for each product milestone. ● Ensure all system-level documentation complies with ISO 13485, ISO 14971, IEC 60601, IEC 62304, and usability norms. ● Coordinate deliverables with mechanical, electronics, embedded, V&V, usability, and regulatory teams. ● Provide regular technical status updates to the Project Manager, including risk flags, component delays, and dependency shifts. ● Work closely with the Project Manager to support deliverable tracking, timeline reviews, and milestone readiness.Qualifications: ● Bachelor’s or Master’s degree in Mechanical, Electronics, Mechatronics, or Biomedical Engineering. ● 6+ years of experience in medical device product development. ● Must have led the end-to-end development and integration of at least two medical devices. ● Proven hands-on experience in at least one core domain (e.g., mechanical, electronics, embedded systems, or software), along with a sound understanding of other domains to enable effective cross-functional collaboration and technical integration. ● Exposure to design for manufacturing (DFM/DFA), sterilization compatibility, and design controls under ISO 13485. ● Systems thinking and deep attention to cross-domain interactions. ● Proactive communicator and integrator across technical functions.
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