SYSTEM ENGINEER

System Engineer

The 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 and SDLC

Very good experience in hardware, software, firmware

Excellent communication skills

System requirements specification (SyRS)

Product requirements document (PRD)

Ensure traceability using requirements traceability matrix (RTM)

Regulatory & compliance

Cross-functional collaboration

Work with:

• R&D (HW/SW/Systems)
• Quality assurance (QA)
• Regulatory affairs (RA)
• Manufacturing & supply chain
• Clinical & marketing teams

Drive:

• Issue resolution
• Design reviews and decision-making

Onsite coordinator responsibilities

Primary interface between customer (onsite) and offshore delivery teams