Support/lead deliverables on technical and patient safety Essential Duties And Responsibilities
• Work End-to End Medical Product Development Cycle per QMS(Requirement Analysis, Design Specs, Sub-system Integration, Verification, release, transfer, production issue etc.).
• Work with cross-functional teams across engineering poles, system, hardware, QA, sourcing, manufacturing, service and marketing teams.
• Develop, modify, and approve electrical documentation, specifications and drawings.
• Create and communicate design/test plans, tasks, deliverables and status.
• Manages time and resources to meet committed schedule milestones. Qualifications
• Embedded Hardware, Firmware/RTOS, requirement writing (functional), System Architecture, System Lead, contribution to system roadmap(portfolio) planning.
• Design fundamentals per CFR21, IEC, ISO13485, ISO14971, MDD/MDR and country regulation for medical equipment.
• Valuable knowledge on RMF, DFMEA. Education And Experience
• A graduate or a post graduate in Electrical or Electronics or related engineering or equivalent Engineering and 12+ years of experience.
• A demonstrated track record in electromechanical hardware design & development, preferably medical devices or other highly regulated products.
• Specific experience in design and development of sensing subsystems (flow, pressure sensors) highly desirable.
📌 Principal Eng, Electrical (India)
🏢 Foundit
📍 India