GlobalLogic
Lead C# Engineer (Medical Devices) IRC281079
Lead Software Engineer in Engineering, 5‑10 years of experience, located in Poland. Skills: .net, C#, cyber security, NIST, TCP/IP, USB. This role is with an innovative U.S. manufacturer of medical devices, focusing on software that processes medical device data to identify health trends and track daily activities. The position offers full involvement in the development life cycle, including end‑to‑end testing of medical devices. Requirements
Education: Bachelor’s in Computer Science, Computer Engineering, Electrical Engineering, or related field (10+ years relevant experience) or Master’s (8+ years experience). Minimum 2+ years in a security‑focused role or hands‑on secure systems development. Strong programming in C# or similar modern OOP language. Experience with regulated QA processes (medical device, FAA, SEC, DoD, Title 21 CFR Part 11). Embedded serial communication (UART, USB). Secure coding practices, authentication, encryption, and vulnerability management. Industrial network security, OT cybersecurity, or IT‑OT integration (highly desirable). Python or other scripting for automation (plus). Certifications: CISSP, CEH, CSSLP, or equivalent (nice to have). Job Responsibilities
Design and develop secure, high‑quality C# software for manufacturing tools and fixtures used in cardiac monitoring device production. Lead design, implementation, and documentation of secure software systems supporting manufacturing and production processes. Define and enforce cybersecurity best practices throughout the SDLC, including code reviews and vulnerability assessments. Apply NIST SP 800‑series controls, MFA, identity management, and cryptographic best practices. Collaborate with manufacturing engineering, IT/OT, quality, and regulatory functions to meet operational and security requirements. Develop and maintain secure interfaces between manufacturing equipment and enterprise systems. Support compliance with FDA Premarket Cybersecurity Guidance, ISO/IEC 81001‑5‑1, IEC 62304, ISO 13485, and other standards. Guide and mentor teams on secure coding, risk mitigation, and cybersecurity standards. Support V&V activities and documentation aligned with regulatory frameworks. Investigate and resolve complex security and performance issues across the manufacturing stack. Drive continuous improvement and promote a culture of quality and security. What We Offer
Culture of caring.
Inclusive environment where people come first. Learning and development.
Training, curricula, and career growth opportunities. Interesting & meaningful work.
Impactful projects on cutting‑edge solutions. Balance and flexibility.
Varied career areas and work arrangements. High-trust organization.
Integrity, ethical values, and transparency in everything. About GlobalLogic
GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest companies, driving digital transformation and innovation across industries.
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Lead Software Engineer in Engineering, 5‑10 years of experience, located in Poland. Skills: .net, C#, cyber security, NIST, TCP/IP, USB. This role is with an innovative U.S. manufacturer of medical devices, focusing on software that processes medical device data to identify health trends and track daily activities. The position offers full involvement in the development life cycle, including end‑to‑end testing of medical devices. Requirements
Education: Bachelor’s in Computer Science, Computer Engineering, Electrical Engineering, or related field (10+ years relevant experience) or Master’s (8+ years experience). Minimum 2+ years in a security‑focused role or hands‑on secure systems development. Strong programming in C# or similar modern OOP language. Experience with regulated QA processes (medical device, FAA, SEC, DoD, Title 21 CFR Part 11). Embedded serial communication (UART, USB). Secure coding practices, authentication, encryption, and vulnerability management. Industrial network security, OT cybersecurity, or IT‑OT integration (highly desirable). Python or other scripting for automation (plus). Certifications: CISSP, CEH, CSSLP, or equivalent (nice to have). Job Responsibilities
Design and develop secure, high‑quality C# software for manufacturing tools and fixtures used in cardiac monitoring device production. Lead design, implementation, and documentation of secure software systems supporting manufacturing and production processes. Define and enforce cybersecurity best practices throughout the SDLC, including code reviews and vulnerability assessments. Apply NIST SP 800‑series controls, MFA, identity management, and cryptographic best practices. Collaborate with manufacturing engineering, IT/OT, quality, and regulatory functions to meet operational and security requirements. Develop and maintain secure interfaces between manufacturing equipment and enterprise systems. Support compliance with FDA Premarket Cybersecurity Guidance, ISO/IEC 81001‑5‑1, IEC 62304, ISO 13485, and other standards. Guide and mentor teams on secure coding, risk mitigation, and cybersecurity standards. Support V&V activities and documentation aligned with regulatory frameworks. Investigate and resolve complex security and performance issues across the manufacturing stack. Drive continuous improvement and promote a culture of quality and security. What We Offer
Culture of caring.
Inclusive environment where people come first. Learning and development.
Training, curricula, and career growth opportunities. Interesting & meaningful work.
Impactful projects on cutting‑edge solutions. Balance and flexibility.
Varied career areas and work arrangements. High-trust organization.
Integrity, ethical values, and transparency in everything. About GlobalLogic
GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest companies, driving digital transformation and innovation across industries.
#J-18808-Ljbffr