Ledgent Technology
Senior Software Engineer
Burnsville, Minnesota, USA · Senior · Full-time
Sponsorship not specified$110k-$160kDetected 47 days ago
JavaC++AzureCI/CDDevOpsProduct ManagementEmbedded SystemsFDA RegulatoryMedical DevicesProblem Solving
About the role
- Senior Software Engineer - Med Device Location: South Metro, Twin Cities (hybrid schedule on-site) Compensation: $110,000-$160,000 base salary plus annual bonus opportunity Job Type: Full-time Role Overview This role is responsible for the design, development, and sustainment of software used in regulated medical products and supporting manufacturing
- operations. The engineer will contribute across the full product lifecycle, collaborating with cross functional teams to deliver reliable, safe, and compliant software solutions. Key Responsibilities Product Software Development Design and implement software components supporting medical products, spanning embedded firmware through graphical user
Responsibilities
- Collaborate with hardware, quality, regulatory, clinical, marketing, and operations teams to define system and software requirements.
- Develop and maintain automated test frameworks, including unit, integration, and system-level tests.
- Support verification and validation (V&V) activities throughout development and release cycles.
- Assist with design transfer to manufacturing and provide ongoing support for fielded products, including post-market software updates.
- Review field performance data, customer feedback, and defect trends to identify improvement opportunities and drive corrective actions.
- Create and maintain comprehensive documentation such as software requirements, architecture diagrams, detailed designs, traceability matrices, and risk analyses.
- Product Development & Cross-Functional Support Participate actively in product development projects to ensure schedules, quality, and compliance expectations are met.
- Ensure all development activities align with internal Quality Management System (QMS) and design control procedures.
- Partner with operations and manufacturing teams to ensure solutions are production-ready and scalable.
- The engineer will contribute across the full product lifecycle, collaborating with cross functional teams to deliver reliable, safe, and compliant software solutions.
Requirements
- Ability to communicate complex technical concepts clearly to technical and non-technical stakeholders.
- Familiarity with FDA 510(k), PMA submissions, EU MDR technical documentation, cybersecurity requirements, and post-market surveillance.
- Prior experience working in a startup or fast-growing product development environment.
- Qualifications Required Bachelor's degree in Computer Science, Software Engineering, or a related technical discipline; advanced degree preferred.
- Preferred Experience with Azure DevOps, static/dynamic code analysis tools, and continuous integration environments.
Nice to have
- Work with marketing teams to translate customer and market requirements into clear software specifications.
- Mentor and guide other engineers on sound software development, documentation, and testing practices.
- Manufacturing Software Design, implement, and validate custom software tools used to support manufacturing and operational processes as required.
- Ensure manufacturing software meets applicable regulatory, quality, and verification standards.
- Required Bachelor's degree in Computer Science, Software Engineering, or a related technical discipline
- advanced degree preferred.
- Strong hands-on expertise in Java, C/C++, real-time operating systems (RTOS), and microcontroller-based embedded systems.
Compensation
- $110,000-$160,000 base salary plus annual bonus opportunity Job Type: Full-time Role Overview This role is responsible for the design, development, and sustainment of software used in regulated medical products and supporting manufacturing operations.
Benefits
- Product Software Development Design and implement software components supporting medical products, spanning embedded firmware through graphical user interfaces.
- Apply industry best practices for safety, reliability, and scalability in compliance with IEC 62304 and FDA Class II/III medical device regulations.
- Minimum of 5 years of software development experience within the medical device industry.
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