Senior Software Engineer

• Develops software used in Imricor products, ranging from firmware to User Interface
• Works closely with hardware, software, quality, regulatory, and clinical teams to define requirements and drive product innovation
• Develops software following best practices for reliability, safety, and scalability and in full compliance with IEC 62304 and FDA Class II/III device requirements
• Develops automated tests, unit tests, integration tests, and supports verification and validation (V&V) activities
• Supports design transfer, manufacturing, and posts market software updates
• Analyzes field data, customer feedback, and defect trends to drive continuous improvement
• Generates and maintains documentation including software requirements, architecture, design specifications, traceability, and risk analysis
• Ensures products are developed per Imricor’s Quality Management System
• Ensures that projects are completed per Imricor’s Design Control processes
• Ensures product development timeline goals are being met
• Works with Marketing to ensure customer requirements are met
• Works with Operations to ensure manufacturability of products
• Mentors other engineers on good engineering and testing practices
• Develops and verifies custom software that is used within the Operation department for manufacturing finished products when needed

• Bachelor of Science in computer science, software engineering, or related technical field
• advanced degree preferred
• Minimum of 5 years of development experience in the medical device industry
• Strong proficiency in Java, C/C++, RTOS, and microcontrollers for embedded systems
• Experience with FDA 510(k), PMA, EU MDR technical documentation and cybersecurity standards, or post market surveillance
• Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
• Strong analytical and problem-solving skills, and comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering

• Experience with Azure DevOps, code analysis tools, and software lifecycle processes a plus
• Previous start-up experience, a plus

Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits