Overview:
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, and
user stories. -
Conduct risk management activities including risk analysis for system, software, and cybersecurity.
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Lead systems integration efforts across various engineering disciplines.
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Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971.
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Ability to effectively work and communicate in technical cross-functional teams to develop new products.
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Continuously improves process and work methodologies by interfacing with peers/crossfunctional groups and analyzing activities to improve work processes.
Qualifications:
Required Qualifications:
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BS Degree in Biomedical/Electrical, Systems/Software Engineering, or related field; Masters preferred
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Minimum of 2-5 years of experience analyzing system requirements, design, and testing
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Software integration, and black box testing methodologies
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Experience with multi-tasking real-time operating system
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Agile development experience
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Strong working knowledge of IEC 60601, IEC 62304, ISO 13485, and ISO 14971
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Experience and understanding of Design Controls and SDLC
Preferred Qualifications:
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Familiarity with best practices of software development for medical devices
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Strong Project Management skills
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Familiarity with Agile, GitHub, and Azure Dev Ops
Physical Requirements:
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Works under general office environmental conditions
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Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
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Ability to travel 25% of the time
