Manager, Software Development

Gilero; Durham, Northern (NC, KY); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with match

Paid parental leave

Paid time off

LinkedIn Learning

Career growth

Job summary

Gilero, a Sanner Group company, seeks an experienced Software Development Manager to lead the embedded software team for medical device and drug delivery applications. You will drive software architecture, lifecycle processes, and regulatory compliance (IEC 62304) while collaborating with electrical, hardware, and systems engineers.

Responsibilities include hands-on firmware design, design controls, V&V, and preparing documentation for premarket submissions.

Qualifications

• Bachelor's degree in Computer Science, Engineering, or related technical field.
• Minimum 10 years of embedded software development experience for medical devices.
• Working knowledge of IEC 62304, ISO 13485, and FDA regulations.

Responsibilities

• Lead the embedded software team across full development lifecycle.
• Define and implement software processes aligned with regulatory standards.
• Hands-on firmware development and UI design as needed.
• Develop software architecture strategy for scalable, reliable systems.
• Oversee design controls, requirements, risk assessments, and V&V reports.
• Prepare software documentation for premarket submissions.

Skills

Embedded software

Leadership

Regulatory compliance

C/C++/Python

CI/CD

Education

Bachelor's degree in CS/Engineering

Tools

GitLab

Tessy

Docker

JIRA

JAMA

Job description

Do you have a passion for helping bring innovative medical devices and drug delivery products to market that improve patients’ lives? Gilero, a Sanner Group company, is seeking an experienced Software Development Manager. You will be responsible for managing the embedded software development team and leading software project activities for medical device and drug delivery applications.

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
• 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 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.
• 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.
• Thrives in a fast-paced, entrepreneurial and growth-oriented environment.
• Highly self-motivated, proactive and accountable, with a strong drive to identify and win new business.
• Commercially minded, with the ability to balance customer needs with business objectives.
• Committed to delivering an exceptional level of service to both external and internal customers.
• Collaborative by nature and comfortable working across technical, operational and commercial teams
• Adheres to established policies and procedures, while contributing to continuous improvements

Eligibility To Work

• 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.

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our teams continue to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Durham, Greensboro, and Pittsboro.
You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month after you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.

What We Offer

• Competitive base salary plus incentive compensation
• Annual performance bonus
• Medical, dental, and vision insurance (multiple BCBS medical plan options)
• Company-paid life insurance
• Company paid life insurance, short- and long-term disability coverage
• 401(k) with company match beginning the first month after you start and immediate vesting in company match
• Paid parental leave
• Paid Time Off and company holidays
• LinkedIn Learning for professional development
• Career growth opportunities within Gilero and the global Sanner Group