OverviewThis role is responsible for ensuring the overall functionality, safety, and efficacy of medical devices. Manages the design, development, and integration of firmware, software, hardware, electronics, and disposables.
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.
- Ability to effectively work and communicate in technical cross-functional teams to develop new products.
- Continuously improves process and work methodologies by interfacing with peers/crossfunctional groups and analyzing activities to improve work processes.
QualificationsRequired Qualifications:- 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 Qualifications:- Familiarity with best practices of software development for medical devices
- Strong Project Management skills
- Familiarity with Agile, GitHub, and Azure Dev Ops
Physical Requirements:- Works under general office environmental conditions
- Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
- Ability to travel 25% of the time
