Senior Software Engineer- Capital Equipment

About the role

The Senior Software Engineer will be responsible for developing software that is used in capital equipment products. This position's work will directly support real-time navigation, device control, and electrophysiology workflows inside the MRI environment, enabling safer, radiation free cardiac interventions. This position may involve other duties from time to time that are not listed below. This position is responsible for complying with the Quality System requirements and carrying out responsibilities outlined in the environmental, health, and safety policies.

Responsibilities

• Product development:
  • 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.
• Participates in product development projects, including:
  • 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.
• Responsible for software used within manufacturing: Develops and verifies custom software that is used within the Operation department for manufacturing finished products when needed.

Requirements

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

Working conditions

Light work, exerting up to 20 lbs. of force or less. Requires fingering, repetitive motion, talking, and hearing. 85% of the time requires viewing and working on a computer screen. Significant work pace & pressure due to deadlines. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.