System Engineer (Medical Device Software)

Location: Kyiv, Ukraine; hybrid office attendance, 3 days in the office and 2 days remotely

Company

hirify.global develops 3D scanners and software solutions for dental and hearing professionals, serving customers in more than 130 countries.

What you will do

• Support the Project Manager and Architect in maintaining a complete, consistent, and audit-ready Design History File.
• Coordinate design inputs and outputs, architecture documentation, requirements, traceability matrices, risk evidence, verification and validation evidence, and release documentation.
• Support system architecture documentation, subsystem decomposition, software component descriptions, system boundaries, and key design decisions.
• Maintain traceability between user needs, requirements, architecture, risks, verification, and validation evidence.
• Support release readiness and audit preparation by identifying documentation gaps, inconsistencies, missing evidence, and approval issues.
• Prepare structured documentation overviews and evidence summaries for decisions by the Project Manager and Architect.

Requirements

• Experience supporting regulated product development, preferably medical device software.
• Understanding of design controls, Design History File structure, requirements engineering, system architecture, traceability, and release documentation.
• Working knowledge of ISO 14971 risk management and medical device QMS expectations.
• Experience coordinating documentation across engineering, QA/RA, risk management, and verification and validation stakeholders.
• Strong analytical thinking, written communication, attention to detail, and ability to simplify complex technical topics.
• Suitable backgrounds may include Requirements Engineer, Business Analyst, Technical Project Manager, Quality Engineer, Verification and Validation Engineer, Software Architect, or Regulatory and Compliance Specialist with relevant regulated-product experience.

Culture & Benefits

• Meaningful work focused on advancing dentistry through medical device software and 3D scanning solutions.
• Professional, friendly, and supportive working environment with ongoing development opportunities.
• 24 working days of annual vacation, medical insurance, paid sick leave, and maternity and paternity leave.
• Breakfasts and lunches, free employee parking, and a comfortable office in UNIT.City.
• Occasional business trips to Western Europe.