Senior Software Engineer – Interoperability
Leo Cancer Care · Middleton, WI · 1 mo ago
HybridFull-time
Key responsibilities
- Lead the design, specification, and implementation of DICOM-RT interoperability features, including RT Plan, RT Dose, RT Structure Set, RT Image, and RT Ion Plan objects.
- Architect and develop network API interfaces enabling communication between the treatment delivery system, OIS (e.g. ARIA, Mosaiq), and PACS servers.
- Define and maintain the system’s DICOM Conformance Statement and related integration documentation.
- Drive end-to-end integration testing with clinical systems, including HL7/FHIR messaging where applicable.
- Perform as a technical lead on significant software development projects spanning interoperability and clinical connectivity.
- Write specifications, requirements, design documents, and test protocols for software projects in accordance with IEC 62304 and the company design control process.
- Develop safety-critical software for imaging and treatment delivery systems.
- Work with external partners and clinical customers to develop, validate, and support system interfaces and integrations.
- Contribute to the design and development of service and validation tools for DICOM interoperability.
- Provide engineering support to partners, customers, and field service teams.
- Support regulatory submissions (e.g. 510(k)) as they relate to interoperability and software.
- Contribute to system architecture and software development process improvements.
- Mentor less experienced engineers in interoperability standards and medical device software practices.
- Manage contractors relating to software component development where applicable.
Relevant Knowledge and Skill requirements
- DICOM-RT and Clinical Interoperability
- Deep working knowledge of DICOM-RT standards: RT Plan, RT Dose, RT Structure Set, RT Image, RT Ion Plan, and related SOP classes.
- Practical experience integrating radiotherapy treatment systems with Oncology Information Systems (OIS) such as Varian ARIA or Elekta Mosaiq, and PACS servers.
- Proficiency with DICOM networking protocols: C-STORE, C-FIND, C-MOVE, C-GET, DICOM TLS, Storage Commitment, and Worklist services.
- Experience developing or maintaining a DICOM Conformance Statement.
- Familiarity with HL7 v2 and/or FHIR messaging as used in oncology workflows is advantageous.
- Understanding of IHE Radiation Oncology profiles (e.g. RO-PIR, IHE-RO) is a plus.
- Medical Device Software Engineering
- Proven experience developing medical device software in compliance with IEC 62304, including software lifecycle planning, classification, architecture, unit testing, and maintenance.
- Familiarity with associated standards and guidance: ISO 14971 (risk management), IEC 62443 (cybersecurity), and applicable FDA/CE regulatory requirements for software.
- Experience supporting regulatory submissions (510(k), CE Technical File) for software-intensive medical devices.
- Experience with design and specification of software systems using UML.
- Networking and Software Engineering
- Solid understanding of TCP/IP networking: routing, firewalls, VLANs, TLS/SSL, and network security as it applies to connected medical devices.
- Experience with REST and/or gRPC API design and integration in a clinical or embedded systems context.
- Strong programming skills in Python and at least one of C++, C#, or Java.
- Experience with Linux, shell scripting, and systems-level debugging.
- Proficiency with version control (Git), CI/CD pipelines, and software testing frameworks.
- Experience
- Minimum 5 years of domain-specific experience in medical device software engineering within radiotherapy, radiation oncology, or a closely related imaging/treatment modality.
- 10+ years of total software engineering experience, with demonstrated seniority in at least one prior role, is strongly preferred.
- Experience working in cross-functional teams including clinical physics, systems engineering, quality, and regulatory affairs.
- Ability to mentor and provide technical leadership to less experienced engineers.