Senior Java Software Engineer — Medical Device Apps

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

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.