Staff Software Engineer, Manufacturing Cybersecurity – Medical Devices

Role Overview

• 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, ISO 13485 and ISO /IEC 27001.
• 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 12+ 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.

Tech Stack

• Cyber Security
• Python
• SDLC

Benefits

• medical, dental, and vision insurance (all of which start on your first day)
• paid holidays
• PTO