Senior Research and Development Engineer, Systems
Cook Medical · Greater Bloomington Area · 2 wk ago
EngineeringFull-time
Responsibilities
- Develop system architectures and specifications including: defining user requirements, design inputs, software requirements, feature descriptions, and user stories.
- Conduct risk management activities including risk analysis for system, software, and cybersecurity.
- Lead systems integration efforts across various engineering disciplines.
- Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971.
- Able to effectively work and communicate in technical cross-functional teams to develop new products.
- Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve work processes.
Qualifications
- Required: BS Degree in Biomedical/Electrical, Systems/Software Engineering, or related field; Masters preferred
- Minimum of 2-5 years of experience analyzing system requirements, design, and testing
- Software integration, and black box testing methodologies
- Experience with multi-tasking real-time operating system
- Agile development experience
- Strong working knowledge of IEC 60601, IEC 62304, ISO 13485, and ISO 14971
- Experience and understanding of Design Controls and SDLC
- PREFERRED: Familiarity with best practices of software development for medical devices
- Strong Project Management skills
- Familiarity with Agile, GitHub, and Azure Dev Ops