Software Engineer – Medical Device Software Manufacturing IRC

Staff Software Engineer – Medical Device Software Manufacturing IRC
289514

Designation:
Senior Software Engineer

Function:
Engineering

Experience:

10-15 years

Location:

United States - San Jose CA

Skills:

C, Cryptography, Identity And Access Management, IEC 62304:2006, IEC 81001-5-1:2021, ISO 13485:2012, NIST, Security

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.

Global Logic estimates the starting pay range for this role to be performed remotely in the range of $150K to $180K and reflects base salary only and does not include additional performance‑linked variable compensation, benefits etc that may be applicable for the role. Global Logic takes many factors into consideration in making an offer, including candidate qualifications, work experience, operational needs, travel and onsite requirements, internal peer equity, prevailing wage, responsibilities, and other market and business considerations.

• 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.
• 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.
• 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.
• 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.

• 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…