Engineer Software Biotech

Bayer Healthcare LLC•Indianola, PA

4d•Hybrid

About The Position

This role involves building medical device software for radiology solutions. The engineer will evaluate design choices, prototype technology, and implement technical solutions. A key responsibility is performing software risk analysis and understanding its impact on the design and implementation of medical devices. The position requires designing and developing scalable software architecture and code, participating in code reviews, developing technical documentation, and ensuring compliance with regulatory standards.

Requirements

Master’s in Computer Engineering or closely related quantitative field
1 year experience designing, building & verifying class-2 software in medical devices using Python, C#, Shell scripting, and gRPC frameworks
Designing & documenting software architecture and components of medical devices using UML
Designing interactions between software subsystems using sequence & class diagrams in compliance with FDA 21 CFR 820.30 – Design Controls and IEC 62304 – Software in a Medical Device
Developing applications including daemon & service management, application dependencies, network management and virtual environments using Linux and Windows
Designing & developing class-2 medical devices in compliance with CANOpen CiA425 standards
Using GitHub, Artifactory, SonarQube, CI/CD Pipelines, JIRA, Confluence, RQM, and/or VSCode to develop code for medical devices

Responsibilities

Build medical device software for radiology solutions
Evaluate design choices
Prototype technology
Implement technical solutions
Perform software risk analysis impact on design & implementation of medical devices
Design & develop scalable software architecture and code implementation
Participate in code reviews
Develop technical documentation
Ensure compliance with regulatory standards