Manager, Software & Systems Development - Medical Devices

Job Purpose:

Responsible for managing embedded software development team and leading software project activities for medical device and drug delivery applications.

Duties:

• Manage a team of software engineers and project activities through the full development lifecycle of embedded software solutions while fostering a culture of collaboration, innovation, integrity, and excellence.
• Collaborate with various cross-functional design and development teams including electrical, hardware, and systems engineering.
• Provide oversight and escalation of technical challenges and client communication with support from Design and Development Leadership and Business Development teams.
• Define and implement software development processes and methodologies in alignment with regulatory standards, including IEC 62304.
• Participate in hands-on development of embedded firmware and UI design.
• Create product software architecture strategy, ensuring scalability, reliability, and maintainability of software systems.
• Contribute to the safety classification assessment and update of all software units.
• Lead design controls activities and documentation efforts, including requirements, risk assessments and mitigation, traceability, V&V protocols and reports, coding reviews, and software releases.
• Prepare the software documentation level for premarket submission with regulatory.
• Apply best practices in software development (code reviews, coding conventions, continuous integration, defensive programming, static analysis, design patterns, etc.)
• Communicate effectively with customers and vendors in a technical capacity.
• Serve as an extension of Gilero in supporting business development efforts through technical calls and engineering estimations.
• Provide technical leadership and mentorship to the software development team, fostering a culture of innovation, collaboration, and continuous improvement.

Skills/Qualifications:

• Bachelor’s degree in Computer Science, Engineering, or related technical field; advanced degree preferred.
• Proven experience (minimum 10 years) in embedded software development for medical devices, combination drug devices, or other regulated industries.
• Proven track record of fully developing embedded software for medical devices.
• Working knowledge in regulatory standards and guidelines, particularly IEC 62304, ISO 13485, and FDA regulations.
• Previous experience in a leadership or managerial role preferred.
• Familiarity with agile methodologies and continuous integration/continuous deployment (CI/CD) practices.
• Experience with various software tools including Gitlab, Tessy, Docker, JIRA, JAMA, preferred.
• Knowledge of cybersecurity principles and considerations in medical device software development, preferred.
• Excellent communication skills with the ability to effectively collaborate with diverse stakeholders and present technical concepts to non-technical audiences.
• Proficiency with C/C++/C#/Python and equivalent frameworks.

Personal Attributes:

• Meets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity
• Productive in a fast-paced, entrepreneurial environment.
• Commits to excellence and quality service to external and internal customers.
• Adheres to established policies and procedures, while contributing to continuous improvements.