Senior Software Engineer

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., * Design and implement software components supporting medical products, spanning embedded firmware through graphical user interfaces.

• Collaborate with hardware, quality, regulatory, clinical, marketing, and operations teams to define system and software requirements.
• Apply industry best practices for safety, reliability, and scalability in compliance with IEC 62304 and FDA Class II/III medical device regulations.
• 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.
• Work with marketing teams to translate customer and market requirements into clear software specifications.
• Partner with operations and manufacturing teams to ensure solutions are production-ready and scalable.
• 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.

• Bachelor’s degree in Computer Science, Software Engineering, or a related technical discipline; advanced degree preferred.
• Minimum of 5 years of software development experience within the medical device industry.
• Strong hands-on expertise in Java, C/C++, real-time operating systems (RTOS), and microcontroller-based embedded systems.
• Proven experience developing regulated software under formal lifecycle processes.
• Strong analytical, problem-solving, and troubleshooting skills.
• Ability to communicate complex technical concepts clearly to technical and non-technical stakeholders.
• Comfortable collaborating across multiple engineering and functional disciplines.

Preferred

• Experience with Azure DevOps, static/dynamic code analysis tools, and continuous integration environments.
• 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.