Senior Software Engineer, R&D

Basic Function

The Senior Software Engineer will be responsible for developing software that is used in capital equipment products.  Your 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.  T
his position is responsible for complying with the Quality System requirements and carrying out responsibilities outlined in the environmental, health, and safety policies.

Responsibilities

Responsible for product development:

·        Develop software used in Imricor products, ranging from firmware to User Interface.

o  Work closely with hardware, software, quality, regulatory, and clinical teams to define requirements and drive product innovation.

o  Develop software following best practices for reliability, safety, and scalability and in full compliance with IEC 62304 and FDA Class II/III device requirements.

o  Develop automated tests, unit tests, integration tests, and support verification and validation (V&V) activities.

o  Support design transfer, manufacturing, and post market software updates.

o  Analyze field data, customer feedback, and defect trends to drive continuous improvement.

o  Generate and maintain documentation including software requirements, architecture, design specifications, traceability, and risk analysis.

·        Participate in product development projects, including:

o  Ensure products are developed per Imricor’s Quality Management System.

o  Ensure that projects are completed per Imricor’s Design Control processes.

o  Ensure product development timeline goals are being met.

·        Work with Marketing to ensure customer requirements are met.

·        Work with Operations to ensure manufacturability of products.

·        Mentor other engineers on good engineering and testing practices.

Responsible for software used within manufacturing:

·        May develop and verify custom software that is used within the Operation department for manufacturing finished products.

Basic Qualifications

• BS in computer science, software engineering, or related technical field; advanced degree preferred.
• Minimum of 5 years of 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.