This position leads software development for medical device products in China and supports lifecycle engineering projects for injectors that are launched in China. The role will support the China 4 China (Dragon Bridge) manufacturing project and also be involved with customer co-creation activities in the China Radiology market.
This position requires a software engineer to support all our existing injector products, collaborate with customers to enhance solutions, and provide technical support for software in manufacturing & product supply environments.
YOUR TASKS AND RESPONSIBILITIES
- Software Development & Support: Maintain, enhance, and troubleshoot existing software applications built with C#, WPF, and .NET to ensure reliability, performance and improving customer satisfaction. Leads designing and developing applications and services using SDLC process for medical device development.
- Technical Documentations: Create and maintain architecture & design documentation, assisting cross functional team such as Regulatory Affairs on user manuals, and training materials for both internal teams and customers. Develop any technical documentation needed to accurately represent application design and code.
- Collaboration with Cross-Functional Teams: Work closely with Regulatory Affairs, Software Development, Verification and Validation, System Engineering, DevOps, and Product Management to implement customer-driven software improvements.
- Customer Co-Creation: Interacts with customers and stakeholders to understand their needs, gather feedback, and collaboratively develop software solutions that improve user experience and functionality.
- Manufacturing Support: Assist in the deployment, configuration, and maintenance of software solutions used in manufacturing environment, ensuring seamless operation.
- Bug Fixing & Issue Resolution: Identify, diagnose, and resolve software defects reported on the fielded products.
- GUI Enhancements: Improve the Injector GUI based on user feedback and modern design principles to enhance usability.
- Software Architecture: Provide guidance for technical design and architecture decisions within and across teams.
- Ensures the development initiatives of Bayer Radiology medical devices complies and adheres to Bayer Standard Operating Procedures that meets regulatory standards and guidance such as
IEC 62304 – Software in a Medical Device
IEC 82304 – Software as a Medical Device
NMPA guidelines
- Works with team and global program leads to manage project priorities, deadlines, and deliverables.
- Anticipates foreseeable technical situations, analyzing, identifying problems, and directing technical resources.
- Be an advocate for software engineering with other groups inside of Bayer Radiology.
- Build relationships with key members of partner organizations.
WHO YOU ARE
- Bachelor’s degree in computer engineering, Electronics, or Electrical Engineering
- Minimum of 10 years of relevant work experience in software engineering including all phases of SDLC
- Significant and long-term experience of relevant medical device software development in a regulated environment
- Deep understanding of software development processes, software architecture, data structure and compliance as it relates to medical device software.
- Expertise in programming languages and framework: C#, C++, NET, JavaScript, Node.js, and Angular
- Database Technologies including SQL, MongoDB, NoSQL, PostgreSQL
- Working knowledge of tools and technologies including GitHub, Jira, Confluence, Artifactory, SonarQube, Rational Quality Manager, Windchill
- Working knowledge on OS such as Windows, Linux flavors
- Demonstrated experience in balancing business needs and technical excellence.
- Strong focus on achievement of goals plus the ability to generate cohesive sup

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