Senior Software Engineer- Capital Equipment

Basic Function

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.

Responsibilities

• Responsible for 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.

Qualifications

• 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.

Pay

$110,000-$140,000 (Minnesota-based position).

Benefits

This position may be eligible for a range of benefits, including Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits.