Lead / Tools Firmware / C# (Medical Devices) IRC282611

Description
Our client is innovative manufacturer of medical devices in the United States which produces a devices and software applications.

At this project, you will have a great opportunity to be involved into the full development life cycle of medical software which is intended to help individuals by processing certain information taken from medical devices to identify health trends and to track daily activities. As additional there are opportunities to work with medical devices, in scope of end-to-end testing.

Requirements
Position Summary:

We are seeking a Staff Software Engineer to lead the development and

implementation of secure manufacturing software solutions supporting medical device

production. The ideal candidate combines deep technical expertise with a strong

understanding of cybersecurity, manufacturing systems, and regulatory compliance.

This is a hybrid position, offering the flexibility to work remotely while maintaining

hands-on collaboration with on-site engineering and operations teams.

Education:

• Bachelor's degree in Computer Science, Computer Engineering,

Electrical Engineering, or a related field with 10+ years of relevant

industry experience, OR

• Master's degree in a related field with 8+ years of experience.

 Experience:

• Minimum 2+ years with a security-focused role or equivalent hands-on

experience implementing secure systems.

• Strong programming skills in C# or a similar modern object-oriented

programming language.

• Familiarity with software QA processes in regulated environments (e.g.,

medical device, FAA, SEC, DoD, Title 21 CFR Part 11) is preferred.

• Experience with low-level embedded serial communication protocols such

as UART, and USB.

• Strong knowledge of secure coding practices, authentication/authorization

mechanisms, encryption standards, and vulnerability management.

• Experience with industrial network security, OT cybersecurity, or

IT/OT system integration is highly desirable.

Experience with Python or other scripting languages for automation or

integration tasks is a plus.

Preferred Certifications (Nice to Have):

 CISSP, CEH, CSSLP, or equivalent security certification.

 Experience with secure development lifecycle or threat modeling frameworks

such as STRIDE or OWASP.

NI-VISA (.NET API): National Instruments' Virtual Instrument Software Architecture (VISA) provides a standardized API for communicating with various instruments over different interfaces like GPIB, serial, USB, and Ethernet. The .NET API allows C# applications to utilize these capabilities Or: SerialPort Class: For simpler serial communication with instruments, the built-in System.IO.Ports.SerialPort class in .NET can be used. Or: Vendor-Specific SDKs: Many instrument manufacturers provide their own C# SDKs or libraries for interacting with their specific devices.

Job responsibilities

• 14 tools that need cyber updates
• 6 tools that have FW update dependency
• Patch FCT, Gateway FVT, Patch BLE, Sangief , Gateway Download, Patch download fixture

Key Responsibilities:
– Design and develop secure, high-quality C# software for manufacturing tools and fixtures used in the production of our Cardiac monitoring devices.

– Lead the design, implementation and documentation of secure software systems that support manufacturing and production processes for medical devices.

– Define and enforce cybersecurity best practices throughout the manufacturing software development lifecycle (SDLC), including code reviews, and vulnerability assessments.

– Familiarity with NIST SP 800-series security controls for software design, including the implementation of Multi-Factor Authentication (MFA), identity

management, and cryptographic best practices.

– Collaborate with manufacturing engineering, IT/OT teams, quality, and regulatory functions to ensure that production software systems meet both operational and security requirements.

– Develop and maintain secure interfaces between manufacturing equipment and other enterprise systems.

– Support compliance with medical device and cybersecurity standards, including FDA Premarket Cybersecurity Guidance, ISO/IEC , IEC 62304, and ISO 13485.

– Guide and mentor development teams on secure coding principles, risk

mitigation, and compliance with cybersecurity standards.

– Support verification and validation activities, including documentation aligned

with medical device regulatory frameworks

– Investigate and resolve complex security and performance issues across the

manufacturing software stack.

– Contribute to continuous improvement initiatives and champion a culture of "doing things right the first time" while maintaining delivery velocity.

What we offer

Culture of caring.
At GlobalLogic, we prioritize a culture of caring. Across every region and department, at every level, we consistently put people first. From day one, you'll experience an inclusive culture of acceptance and belonging, where you'll have the chance to build meaningful connections with collaborative teammates, supportive managers, and compassionate leaders.

Learning and development.
We are committed to your continuous learning and development. You'll learn and grow daily in an environment with many opportunities to try new things, sharpen your skills, and advance your career at GlobalLogic. With our Career Navigator tool as just one example, GlobalLogic offers a rich array of programs, training curricula, and hands-on opportunities to grow personally and professionally.

Interesting & meaningful work.
GlobalLogic is known for engineering impact for and with clients around the world. As part of our team, you'll have the chance to work on projects that matter. Each is a unique opportunity to engage your curiosity and creative problem-solving skills as you help clients reimagine what's possible and bring new solutions to market. In the process, you'll have the privilege of working on some of the most cutting-edge and impactful solutions shaping the world today.

Balance and flexibility.
We believe in the importance of balance and flexibility. With many functional career areas, roles, and work arrangements, you can explore ways of achieving the perfect balance between your work and life. Your life extends beyond the office, and we always do our best to help you integrate and balance the best of work and life, having fun along the way

High-trust organization.
We are a high-trust organization where integrity is key. By joining GlobalLogic, you're placing your trust in a safe, reliable, and ethical global company. Integrity and trust are a cornerstone of our value proposition to our employees and clients. You will find truthfulness, candor, and integrity in everything we do.

About GlobalLogic
GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world's largest and most forward-thinking companies. Since 2000, we've been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.