Project Engineer – HX Now (Snke Mobile)

snke

🇩🇪 Germany

Hybrid

1 week ago

EHR
IEC
SAP
FHIR
GitHub
Technical Writing
HL7
DICOM

1 week ago

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As aProject Engineer at Snke Mobile, you will own the documentation and quality-process backbone of HX Now, our mobile platform that brings Snke and partner workflows to hospital staff and connects meaningfully with hospital IT systems (EHR/HIS). You will be part of a small, cross-functional team building a regulated medical product (MDR / ISO 13485 / IEC 62304). You will work closely with our Product Owner, who stays hands-on with the app, the development team, and testing, while you own the documentation and regulatory-process side. The exact division of tasks between you and the Product Owner will be shaped together and will evolve as the team and the product grow. You will also help shape how HX Now moves from its current SAP i.s.h.med integration toward the Snke FHIR Server and FHIR-based Connectors.

Own the documentation set for HX Now — service and user documentation, installation and configuration documentation, release documentation, and regulatory records — keeping it accurate, practical, and audit-ready
Ensure all release documentation is complete and on time for each regulatory checkpoint, working within Snke's QMS and Development Process
Own requirement, risk, and test documentation, including requirement-to-test traceability and a clean, well-maintained backlog in GitHub
Prepare and document regulatory affairs meetings, record the resulting measures, and track them through to closure
Maintain security and risk documentation in line with MDR and IEC 62304 expectations
Coordinate with our QMS team on templates, processes, and deadlines across all project documentation
Support the transition to Snke's FHIR-based architecture (Snke FHIR Server, Connectors, Snke Forms), including coordination with the Data Integration team on shared dependencies

Completed training in health/medical informatics, digital health, computer science, or a comparable field (a university degree is not strictly required)
Working knowledge of medical device software standards and processes — ISO 13485, IEC 62304, MDR — including an understanding of why they exist, not only how to follow them
Experience in a documentation-, quality-, or regulatory-focused role, ideally within a regulated medical device or healthtech environment
Strong technical writing skills, able to turn complex product and clinical workflows into clear service and user documentation
A structured, reliable, well-organized work style, with the persistence to chase open points down to a real answer
Genuine enjoyment of close teamwork in a small, cross-functional team, and the flexibility to shape a shared workload with the Product Owner as the role develops
Understanding of healthcare interoperability standards (FHIR, HL7, DICOM) is an advantage
Outstanding presentation and communication skills in English and German

A supportive, international team connected by shared values and a culture of trust
Meaningful responsibilities with a lasting impact on global healthtech, improving medical decisions and patient outcomes
30 vacation days, plus December 24th and December 31st
Flexible working hours and a hybrid work model within Germany
Bike leasing via our partner “BikeLeasing”
Parking garage and secure underground bike storage
Subsidized company restaurant and in-house café
Urban Sports Club membership with employer contribution
Regular after-work, team, and company events
Centrally located, modern workspace with a 212 m² rooftop terrace

Ready to apply? We look forward to receiving your online application including your first available start date.Tatjana von Freyberg

Project Engineer – HX Now (Snke Mobile) · snke

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