Senior Software Engineer- Capital Equipment

Description

Supervisor’s Title: Senior R&D Engineering Manager  
Exempt Status: Exempt

Location: Must be able to work onsite at the Burnsville location  

Compensation: The expected salary for this Minnesota-based position is $110,000-$140,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).

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.  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

Responsible for product development:

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

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

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

o Develops automated tests, unit tests, integration tests, and supports verification and validation (V&V) activities.

o Supports design transfer, manufacturing, and posts market software updates.

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

o Generates and maintains documentation including software requirements, architecture, design specifications, traceability, and risk analysis.

· Participates in product development projects, including:

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

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

o 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

Basic 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.

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.

The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such above. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.