Manager, Software Development

GILERO•Durham, NC

About The Position

Gilero, a Sanner Group company, is seeking an experienced Software Development Manager to manage the embedded software development team and lead software project activities for medical device and drug delivery applications. The role involves fostering a culture of collaboration, innovation, integrity, and excellence, and working with cross-functional teams to bring innovative medical devices and drug delivery products to market that improve patients’ lives.

Requirements

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 and/or combination drug devices.
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.
Familiarity with agile methodologies and continuous integration/continuous deployment (CI/CD) practices.
Proficiency with C/C++/C#/Python and equivalent frameworks.
Excellent communication skills with the ability to effectively collaborate with diverse stakeholders and present technical concepts to non-technical audiences.
Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
Gilero does not offer sponsorship for employment authorizations (work visas).
We are an E-Verify employer and confirm work authorization for all new hires.

Nice To Haves

Experience with various software tools including Gitlab, Tessy, Docker, JIRA, JAMA, preferred.
Knowledge of cybersecurity principles and considerations in medical device software development, preferred.

Responsibilities

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.