Manager, Software Development

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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

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 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