This 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, anduser 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.
Required Qualifications:
- BS Degree in Biomedical/Electrical, Systems/Software Engineering, or related field; Masters preferred
- Minimum of 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
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What We Do
At Cook, we are building our future on Invention, Connection, People, and Community. As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device. Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.
