System Engineer – Medical Device Software Project

Kyiv, hybrid office (3/2)

About us

3Shape  develops 3D scanners and software solutions that enable dental and hearing professionals to treat more people, more effectively. Our products are market leading innovative solutions that make a real difference in the lives of both patients and dental professionals around the world.

3Shape is headquartered in Copenhagen, with development teams in Denmark, Ukraine, North Macedonia  and with a production site in Poland.

We are a global company with presence in Europe, Asia and the Americas. Founded in a year 2000, today, we provide services to customers in over 130 countries. Our growing talent pool of over 2200 employees spans 50 nationalities.

3Shape as an employer is committed to Ukraine.  Our UA office was founded in 2006, and we are continuing to grow, hire and take care of our employees even during the war in Ukraine. Among other actions, we support our contractors who are called to the military service, as well as care about our colleagues’ mental health by implementing different activities.

About the role:

This role supports the Project Manager and Architect in maintaining system engineering-related documentation and coordination for a medical device software project. The role is not intended to carry full end-to-end responsibility for System Engineering activities. Instead, it provides structured support for Design History File (DHF) maintenance, architecture and requirements documentation, traceability, release readiness, and audit preparation.

The role works closely with the Project Manager, Architect, QA/RA, Risk Management, Verification and Validation, and development stakeholders to ensure documentation is complete, consistent, traceable, and aligned with applicable QMS and regulatory expectations.

Areas of responsibility:

1. DHF and Documentation Support

Support the Project Manager and Architect in maintaining a complete, consistent, and audit-ready DHF. This includes coordination of design inputs and outputs, architecture documentation, traceability matrices, risk-related evidence, verification and validation evidence, and release documentation.

Help ensure documentation is properly structured, versioned, reviewed, approved, and stored in accordance with QMS expectations and project procedures.

2. System Definition and Architecture Support

Support the Architect in maintaining system-level architecture, subsystem decomposition, software component descriptions, system boundaries, and key design decisions. Assist in translating user needs and stakeholder inputs into structured, testable requirements.

3. Traceability, Risk, and V&V Support

Support traceability between user needs, requirements, architecture, risks, verification, and validation evidence. Contribute to risk management documentation in accordance with ISO 14971 and help ensure risk controls are linked to requirements and objective evidence.

Assist QA, Risk Management, and V&V stakeholders in maintaining documentation needed to demonstrate that requirements are verified, user needs are validated, and safety-related considerations are addressed.

4. Release Readiness and Audit Preparation

Support release readiness by helping confirm that required documentation, approvals, traceability, V&V evidence, and DHF records are complete and aligned before release. Support audit preparation by identifying documentation gaps, inconsistencies, and missing evidence early.

5. Coordination and Decision Support

Prepare structured inputs, options, documentation overviews, and evidence summaries to support decisions by the Project Manager and Architect. Work independently on assigned documentation and coordination topics while escalating decisions that require formal project or technical ownership.

Expected Outcomes

• DHF is complete, consistent, traceable, release-ready, and audit-ready.

• Architecture, requirements, risk, and V&V documentation are aligned and maintained.

• Documentation gaps and traceability issues are identified and addressed early.

• Project Manager and Architect receive clear, structured support for technical and compliance-related decisions.

Required Experience

• Experience supporting regulated product development, preferably in medical device software.

• Understanding of design controls, DHF structure, requirements engineering, system architecture, traceability, and release documentation.

• Working knowledge of ISO 14971 risk management and medical device QMS expectations.

• Experience coordinating cross-functional documentation across engineering, QA/RA, risk management, and V&V stakeholders.

Alternative Suitable Backgrounds

If direct System Engineer experience is not available, the following backgrounds may also be suitable, provided the candidate has strong documentation discipline, regulated product development experience, and the ability to work across technical and quality functions:

Requirements Engineer / Business Analyst with experience translating user needs into structured requirements and maintaining traceability.

Technical Project Manager / Engineering Project Manager with experience coordinating regulated documentation, release readiness, and cross-functional deliverables.

Quality Engineer / Design Quality Engineer with experience in design controls, DHF maintenance, audit readiness, and risk-related documentation.

Verification and Validation Engineer with experience linking requirements to test evidence and supporting release documentation.

Software Architect / Solution Architect with experience documenting architecture, design decisions, system boundaries, and technical trade-offs in a regulated environment.

Regulatory or Compliance Specialist with strong technical understanding and experience supporting medical device documentation and audit preparation.

Key Skills

• Structured and analytical thinking.

• Clear written communication and ability to simplify complex technical topics.

• Strong attention to detail in regulated documentation.

• Ability to coordinate across project, architecture, quality, risk, and validation stakeholders.

• Ownership of assigned documentation and coordination tasks, with clear escalation of formal decisions to the Project Manager and Architect.

Being the part of us means:

• Meaningful work that helps to change the future of dentistry

• Work in a unique professional, friendly and supportive environment

• Constant professional growth and development

• A healthy work-life balance

• Comprehensive benefits incl. 24 working days of annual vacation; medical insurance; paid sick leaves and child sick leaves; maternity and paternity leaves etc

• Breakfasts and lunches in the office

• Good working conditions in a comfortable office in UNIT.City

• A parking lot with free spaces for employees

• Occasional business trips to Western Europe

• Opportunity to become a part of the success that 3Shape has created over the past 25 years.

We will be glad to welcome you to our team!

For more information, visit our website: www.3shape.com and follow us on Instagram: https://www.instagram.com/3shape_ukraine/

You can contact our Talent Acquisition team via email: [email protected].