Staff Software Engineer – Medical Device Software Manufacturing IRC289514

GlobalLogic is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. They are seeking a Staff Software Engineer to lead the development and implementation of secure manufacturing software solutions supporting medical device production, ensuring compliance with cybersecurity and regulatory standards.

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 81001-5-1, 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

Requirements:

• 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
• 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
• 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
• Core Attributes: Strong analytical and problem-solving skills with a detail-oriented mindset
• Demonstrated ability to balance speed and quality, caring as much about doing things right as getting things done
• Excellent communication skills and ability to influence across multidisciplinary teams
• Proven leadership in mentoring and fostering secure software development practices
• Familiarity with software QA processes in regulated environments (e.g., medical device, FAA, SEC, DoD, Title 21 CFR Part 11) is preferred
• 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