System EngineerThe System & Product Engineer is responsible for end-to-end product development, system engineering, and lifecycle management of IVD devices, ensuring compliance with regulatory standards and customer requirements.
The role also acts as an Onsite Coordinator, bridging communication between offshore teams and customer stakeholders.Experience in Product Development & SDLCVery Good Experience in hardware, Software, FirmwareExcellent Communication SkillsSystem Requirements Specification (SyRS)Product Requirements Document (PRD)Ensure traceability using Requirements Traceability Matrix (RTM)Regulatory & ComplianceCross-Functional Collaboration Work with: R&D (HW/SW/Systems)Quality Assurance (QA)Regulatory Affairs (RA)Manufacturing & Supply ChainClinical & Marketing TeamsDrive: Issue resolutionDesign reviews and decision-makingOnsite Coordinator Responsibilities Primary interface between customer (onsite) and offshore delivery teams