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Search Leaders; Minneapolis (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Search Leaders is seeking a senior software engineer to design and develop Java-based application software powering MRI-guided cardiac devices. You will work at both application and system levels to enable real-time navigation, device communication, and clinical workflows while ensuring compliance with FDA regulations and IEC 62304.

The role requires a Bachelor's degree in CS/SE and 5+ years of medical device software experience, with strong Java expertise and FDA-regulated environment exposure.

Qualifications

• Bachelor's degree in CS/SE or related field.
• Five or more years of software development in medical devices.
• Strong Java experience for application software.
• Experience in FDA Design Controls and IEC 62304.
• Experience supporting FDA 510(k)/PMA or EU MDR submissions.
• Experience developing automated, unit, and integration tests.

Responsibilities

• Design, develop, and maintain Java-based application software powering capital medical equipment products.
• Develop application and system level software enabling real-time navigation, device control, and clinical workflows.
• Collaborate across engineering, regulatory, quality, and manufacturing to define requirements.
• Build software that complies with IEC 62304 and FDA Class II/III standards.
• Develop automated, unit, and integration tests and support Verification & Validation activities.
• Support product lifecycle activities including design transfer and software releases.
• Analyze user feedback and defect trends to improve performance and reliability.
• Create and maintain software requirements, architecture, design specs, and risk assessments.
• Ensure adherence to Quality Management System and Design Control processes.
• Partner with operations and marketing to support manufacturability and product enhancements.
• Mentor engineers on development best practices and testing.

Skills

Java

Medical device industry experience

FDA regulatory experience

Software testing

Analytical skills

Cross-functional collaboration

Education

Bachelor's degree in Computer Science or Software Engineering

Tools

Azure DevOps

Static code analysis tools

Job description

Our client is a pioneering medical technology organization focused on advancing minimally invasive cardiac procedures through innovative MRI compatible solutions that eliminate radiation exposure and improve patient outcomes.

Position Responsibilities

This role is responsible for designing and developing Java based application software that powers advanced medical devices used in MRI guided cardiac procedures. Working at the application and system level, you will build software supporting real time navigation, device communication, clinical workflows, and user interaction while ensuring compliance with FDA regulations and medical device software standards.

• Design, develop, and maintain Java based application software supporting capital medical equipment products.
• Develop application and system level software that enables real time navigation, device control, and clinical workflows.
• Collaborate cross functionally with engineering, clinical, regulatory, quality, and manufacturing teams to define and refine product requirements.
• Build reliable, scalable, and safety compliant software aligned with IEC 62304 and FDA Class II and III medical device standards.
• Develop and execute automated, unit, and integration testing while supporting formal Verification and Validation activities.
• Support product lifecycle activities including design transfer, manufacturing integration, software releases, and post market updates.
• Analyze user feedback, field data, and defect trends to improve product performance and reliability.
• Create and maintain software requirements, architecture documentation, design specifications, traceability, and risk assessments.
• Ensure adherence to Quality Management System and Design Control processes throughout software development.
• Partner with operations and marketing teams to support manufacturability and customer focused product enhancements.
• Mentor software engineers on development best practices, testing methodologies, and software quality.

Position Requirements

• Bachelor's degree in Computer Science, Software Engineering, or related technical field.
• Five or more years of software development experience within the medical device industry.
• Strong Java software development experience building commercial or medical device applications.
• Experience developing application or system level software rather than exclusively embedded firmware.
• Experience working within FDA regulated environments including Design Controls, IEC 62304, software traceability, and software lifecycle documentation.
• Experience supporting FDA 510(k), PMA, or EU MDR regulatory submissions.
• Experience developing automated tests, unit tests, integration tests, and supporting Verification and Validation.
• Experience collaborating across engineering, quality, regulatory, manufacturing, and clinical teams.
• Strong analytical, problem solving, communication, and cross functional collaboration skills.

Preferred Requirements

• Experience with C or C++ for device communication or supporting embedded software.
• Experience with embedded systems, RTOS, or microcontrollers.
• Experience using Azure DevOps, static code analysis tools, and modern software development practices.
• Advanced degree in a related technical field.
• Experience with cybersecurity standards and post market surveillance practices.
• Previous experience in a startup or high growth environment.
• Experience mentoring or providing technical leadership to software engineering teams.

Reasons to Apply

• Competitive salary plus a comprehensive benefits package.
• Health coverage, retirement plans, and other company-sponsored perks.
• Generous paid time off, including holidays, to support work-life balance.
• Flexible schedules and work life balance.
• Strong focus on employee development with on-the-job training and career growth.
• A positive company culture that values diversity and collaboration.

The pay range for this role is:

110,000 - 140,000 USD per year (Minneapolis, MN)