Engineer Software Biotech

Overview

Engineer Software Biotech for Indianola, PA to 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.

• Evaluate design choices and prototype technology for medical device software.
• Implement technical solutions and perform software risk analysis impacting design and implementation.
• Design and develop scalable software architecture and code implementation.
• Participate in code reviews and develop technical documentation.
• Ensure compliance with regulatory standards.
• Take up to 10% U.S. and international travel as required.
• Telecommute from a home office location within reasonable commuting distance of Indianola, PA up to 2 days per week.

• Master’s degree in Computer Engineering or a closely related quantitative field.
• At least 1 year of experience designing, building, and verifying class‑2 software in medical devices using Python, C#, Shell scripting, and gRPC frameworks.
• Experience designing and documenting software architecture and components of medical devices using UML.
• Experience designing interactions between software subsystems with sequence and class diagrams in compliance with FDA 21 CFR 820.30 – Design Controls and IEC 62304 – Software in a Medical Device.
• Experience developing applications including daemon and service management, application dependencies, network management and virtual environments using Linux and Windows.
• Experience designing and developing class‑2 medical devices in compliance with CANO
  
  pen CiA
  425 standards.
• Proficiency with Git Hub, Artifactory, Sonar Qube, CI/CD pipelines, JIRA, Confluence, RQM, and/or VSCode for medical device software development.

• Salary range: $ to $.
• Potential bonus or commission (if relevant).
• Health care, vision, dental, retirement, paid time off, sick leave and other benefits.

Bayer Healthcare LLC is an Equal Opportunity Employer/Disabled/Veterans. Bayer Healthcare LLC is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s). If you meet the requirements, we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.