Software Engineering Manager

Job Title:

Software Engineering Manager

This role leads a software engineering team that designs, develops, and implements software for new and existing medical products. The Software Engineering Manager defines and executes a strategic vision for modern, efficient, and compliant software development processes, procedures, and tools. As a working manager, this person actively contributes to coding and documentation, from user needs through test cases, while ensuring the technical excellence and regulatory compliance of all software delivered by the team.

• Lead, grow, and mentor a team of software engineers, fostering a high-performing and collaborative environment.
• Provide day-to-day technical leadership to software staff and guide them in best practices for software and firmware development.
• Develop, implement, and continuously improve software development procedures and methodologies that comply with medical device regulations and align with current software engineering best practices.
• Select, manage, and coordinate external resources for software validation testing and cybersecurity penetration testing.
• Direct and enhance software and firmware testing methods to ensure compatibility, reliability, and stability across products.
• Provide technical guidance and oversight on software system designs, platforms, and architecture to support new markets and evolving customer needs.
• Direct or create software specifications based on user requirements and product design requirements, ensuring clarity and traceability.
• Write new software and firmware code that reliably functions and performs in accordance with approved software requirement specifications.
• Direct and create manual and automated software bug testing and code reviews to ensure software quality prior to release.
• Direct or create software design documents, flowcharts, and other design output documentation for software and firmware to support product maintenance and verification testing.
• Develop or maintain software for website products, or oversee external resources responsible for this work, as needed.
• Lead sustaining engineering activities for field-reported issues related to existing firmware and software products.
• Actively participate in investigations of issues related to software systems, collaborating with cross-functional teams as required.
• Direct or perform analysis of field-reported issues related to software or firmware performance, identifying root causes and corrective actions.
• Direct and develop new or modified software and firmware code to address and reduce field-reported issues.
• Ensure that all software development activities adhere to relevant medical device safety, software standards, and internal quality systems.
• Coordinate and guide teams located in domestic and international locations to achieve aligned technical and project goals.

• Bachelor’s degree in Software Engineering or Computer Science.
• Twelve or more years of experience in software development after completion of a Bachelor’s degree.
• At least six years of experience in the medical device industry within those twelve or more years.
• At least five years of experience as a Software Engineering Manager leading engineering teams.
• Demonstrated ability to build, lead, and sustain a high-performing software engineering team.
• Demonstrated ability to apply structured problem-solving techniques to achieve positive outcomes.
• Proficiency in programming languages such as C, C++, C#, and SQL.
• Experience in cybersecurity applied to software and medical device environments.
• Strong knowledge of medical device safety and software standards such as IEC and ISO.
• Working knowledge of medical IT infrastructure, cybersecurity requirements, and regulatory compliance expectations.
• Proficiency with code management and version control tools such as Git and Mercurial.
• Ability to direct and collaborate with teams across domestic and international locations.
• Proficiency in standard Microsoft Office applications for documentation, communication, and reporting.
• Experience with embedded firmware development, particularly in medical device contexts.
• Ability to ensure adherence to software…