Project Engineer – HX Now (Snke Mobile)

Snke Inc.; München; Hybrid; EUR 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

30 vacation days

Hybrid work model within Germany

Bike leasing

Urban Sports Club membership

Modern workspace with rooftop terrace

Zusammenfassung

Snke Inc. in Munich is hiring a Project Engineer who will own HX Now documentation and regulatory processes for a regulated medical product.

You’ll work closely with Product Owner, development, and QA to ensure audit-ready records and robust traceability across requirements, risks, and tests. The role involves shaping MDR/IEC 62304 alignment, improving templates, and coordinating with the QMS team while moving toward FHIR-based integration and connectors.

Qualifikationen

• Completed training in health/medical informatics, digital health, computer science, or a comparable field.

Aufgaben

• 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

Kenntnisse

Technical writing

Regulatory knowledge

Team collaboration

English & German

Ausbildung

Health/Medical informatics or Computer Science

Jobbeschreibung

Founded in 2020 and headquartered in Munich, Snke is transforming healthtech with scalable, data-driven innovation powered by AI and big data analytics. We're experts specializing in large platforms, digital health and software-driven medical technology. By delivering a trusted orchestration layer, Snke empowers healthcare providers, societies, registries, agencies and all partners to deploy cutting-edge solutions for safe and efficient interventions and enhances patient outcomes. Beyond our Munich headquarters, we have core teams in Chicago, Heidelberg, San Diego and Tel Aviv. Snke fosters global collaboration to create technologies that are smart, enabling and holistic-helping healthcare providers deliver meaningful change.

What you'll do

As a Project 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

What we're looking for

• 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

Why Snke

• A supportive, international team connected by shared values and a culture of trust
• Meaningfulresponsibilitieswithalastingimpactonglobalhealthtech,improvingmedicaldecisionsandpatientoutcomes
• 30vacationdays,plusDecember24thandDecember31st
• FlexibleworkinghoursandahybridworkmodelwithinGermany
• Bikeleasingviaourpartner“BikeLeasing”
• UrbanSportsClubmembershipwithemployercontribution
• Centrally located, modern workspace with a 212 m² rooftop terrace

• A supportive, international team connected by shared values and a culture of trust
• Meaningfulresponsibilitieswithalastingimpactonglobalhealthtech,improvingmedicaldecisionsandpatientoutcomes
• 30vacationdays,plusDecember24thandDecember31st
• FlexibleworkinghoursandahybridworkmodelwithinGermany
• Bikeleasingviaourpartner“BikeLeasing”
• Parkinggarageandsecureundergroundbikestorage
• Subsidizedcompanyrestaurantandin-housecafé
• UrbanSportsClubmembershipwithemployercontribution
• Regularafter-work,team,andcompanyevents
• Centrally located, modern workspace with a 212 m² rooftop terrace