The leading system Engineer is responsible for designing, testing and improving technology solutions as per the clients product requirements and safety implications. system Engineers work closely with other engineers, designers and product managers to ensure that products meet customers needs and goals.
The Lead system Engineer reports to VP R D.
The Lead system Engineer works closely with the product managers to develop product roadmaps and timelines.
Position Responsibilities and Deliverables
system Architecture Design: Creating and maintaining the overall system architecture, design, and integration strategies for complex electromechanical devices.
Requirements Management: Defining, documenting, and managing system -level requirements, ensuring traceability from user needs and RMF (Risk Analysis) to design outputs.
Requirements: Education: BSc or MSc in Systems, Electrical, Mechanical, SW, Physics or Biomedical Engineering.
Experience: 5+ years in medical device development, with experience in system integration, design controls, and technical leadership.
Domain Expertise: Strong knowledge of ISO 13485, ISO 14971 and other standards concerning development of medical devices and regulations, plus familiarity with multidisciplinary systems.
Skills: Strong communication, cross-functional collaboration, and the ability to work in a global team environment. Familiarity with project management tools and techniques.
Excellent technical writing skills in English for regulatory and design documentation.
This position is open to all candidates.