Manager, Software & Systems Development - Medical Devices

Are you passionate about using cutting-edge technology to improve lives? Join Gilero as a Software and Systems Development Manager and lead the charge in developing embedded software development solutions that will help save and improve lives. This role offers a unique opportunity to elevate your skills in embedded software while working with leading technologies for medical devices and drug delivery systems.

You’ll manage a talented team of engineers, collaborate with cross-functional teams, and drive innovation at the intersection of healthcare and technology. At Gilero, we value integrity, collaboration, and excellence—if you're ready to make an impact while advancing your career, this is your opportunity to lead with purpose and grow in an Agile, mission-driven environment.

Responsibilities:

• Manage the embedded software development team and lead software project activities for medical device and drug delivery applications.
• 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.

Qualifications:

• Ability to work onsite in Durham, NC location.
• 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, managerial, or team lead 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, and IAR Workbench, 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.

Benefits: You will enjoy an annual bonus, Medical (3 BCBS plans to choose from), Guardian dental and vision, short-term and long-term disability, 401K with a 5% match the first month you start with a zero vesting period.