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 addresse
