Job Description

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.
• 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/cross-functional 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