Search Leaders

james.marmas@searchleaders.com

Minneapolis, MN · Senior

Sponsorship not specifiedDetected 15 days ago

JavaC++AzureDevOpsCybersecurityProduct ManagementEmbedded SystemsFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingMentoring

About the role

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.
Analyze user feedback, field data, and defect trends to improve product performance and reliability.
Mentor software engineers on development best practices, testing methodologies, and software quality.

Responsibilities

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.
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.
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.
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 developing automated tests, unit tests, integration tests, and supporting Verification and Validation.

Requirements

Bachelor's degree in Computer Science, Software Engineering, or related technical field.
Experience supporting FDA 510(k), PMA, or EU MDR regulatory submissions.
Experience collaborating across engineering, quality, regulatory, manufacturing, and clinical teams.
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.

Nice to have

Preferred Requirements: Experience with C or C++ for device communication or supporting embedded software.

Compensation

Reasons to Apply: Competitive salary plus a comprehensive benefits package.

Benefits

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.
This role is responsible for designing and developing Java based application software that powers advanced medical devices used in MRI guided cardiac procedures.
Design, develop, and maintain Java based application software supporting capital medical equipment products.
Build reliable, scalable, and safety compliant software aligned with IEC 62304 and FDA Class II and III medical device standards.
Five or more years of software development experience within the medical device industry.
Strong Java software development experience building commercial or medical device applications.

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