SYSTEM ENGINEER

Apolis

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 & 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

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Vacancy posted 2 days ago

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