Sr Systems Analysis Engineer, R&D

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.
• 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