Sr. System Analyst/Engineer

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.Required Qualifications:BS Degree in Biomedical/Electrical, Systems/Software Engineering, or related field; Masters preferredMinimum of 5 years of experience analyzing system requirements, design, and testingSoftware integration, and black box testing methodologiesExperience with multi-tasking real-time operating systemAgile development experienceStrong working knowledge of IEC 60601, IEC 62304, ISO 13485, and ISO 14971Experience and understanding of Design Controls and SDLCPreferred Qualifications:Familiarity with best practices of software development for medical devicesStrong Project Management skillsFamiliarity with Agile, GitHub, and Azure Dev OpsResponsibilities: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.Physical Requirements:Works under general office environmental conditionsSitting for extended periods, utilizes close visual acuity for working with computers, etc.Ability to travel 25% of the time