Engineer Software Biotech

Bayer•Indiana Township, PA

5d•$135,000 - $155,000•Hybrid

About The Position

We are seeking an Engineer Software Biotech for our location in Indianola, PA, to build medical device software for radiology solutions. This role involves evaluating design choices, prototyping technology, and implementing technical solutions. You will perform software risk analysis, assess its impact on the design and implementation of medical devices, and design and develop scalable software architecture and code. Responsibilities include 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 of 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