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Software Development Team Lead
2 months ago
We are seeking a highly experienced and skilled Software Development Team Lead to join our team at Gilero. As a key member of our organization, you will be responsible for leading our embedded software development team and overseeing software project activities for medical device and drug delivery applications.
Key Responsibilities- Team Leadership: Manage a team of software engineers and project activities through the full development lifecycle of embedded software solutions, fostering a culture of collaboration, innovation, integrity, and excellence.
- Cross-Functional Collaboration: Collaborate with various cross-functional design and development teams, including electrical, hardware, and systems engineering.
- Techincal Oversight: Provide oversight and escalation of technical challenges and client communication with support from Design and Development Leadership and Business Development teams.
- Process Development: Define and implement software development processes and methodologies in alignment with regulatory standards, including IEC 62304.
- Hands-On Development: Participate in hands-on development of embedded firmware and UI design.
- Architecture Strategy: Create product software architecture strategy, ensuring scalability, reliability, and maintainability of software systems.
- Safety Classification: Contribute to the safety classification assessment and update of all software units.
- Design Controls: Lead design controls activities and documentation efforts, including requirements, risk assessments and mitigation, traceability, V&V protocols and reports, coding reviews, and software releases.
- Documentation: Prepare the software documentation level for premarket submission with regulatory.
- Best Practices: Apply best practices in software development, including code reviews, coding conventions, continuous integration, defensive programming, static analysis, design patterns, etc.
- Communication: Communicate effectively with customers and vendors in a technical capacity.
- Business Development: Serve as an extension of Gilero in supporting business development efforts through technical calls and engineering estimations.
- Technical Leadership: Provide technical leadership and mentorship to the software development team, fostering a culture of innovation, collaboration, and continuous improvement.
- Education: Bachelor's degree in Computer Science, Engineering, or related technical field; advanced degree preferred.
- Experience: Proven experience (minimum 10 years) in embedded software development for medical devices, combination drug devices, or other regulated industries.
- Track Record: Proven track record of fully developing embedded software for medical devices.
- Regulatory Knowledge: Working knowledge in regulatory standards and guidelines, particularly IEC 62304, ISO 13485, and FDA regulations.
- Leadership Experience: Previous experience in a leadership or managerial role preferred.
- Methodologies: Familiarity with agile methodologies and continuous integration/continuous deployment (CI/CD) practices.
- Software Tools: Experience with various software tools, including Gitlab, Tessy, Docker, JIRA, JAMA, preferred.
- Cybersecurity: Knowledge of cybersecurity principles and considerations in medical device software development, preferred.
- Communication Skills: Excellent communication skills with the ability to effectively collaborate with diverse stakeholders and present technical concepts to non-technical audiences.
- Programming Skills: Proficiency with C/C++/C#/Python and equivalent frameworks.
- Core Values: Meets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity
- Entrepreneurial Spirit: Productive in a fast-paced, entrepreneurial environment.
- Commitment to Excellence: Commits to excellence and quality service to external and internal customers.
- Continuous Improvement: Adheres to established policies and procedures, while contributing to continuous improvements.
