Staff Software Engineer Manufacturing Software (Medical Devices) IRC280090

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:
o Bachelor’s degree in Computer Science, Computer Engineering,
Electrical Engineering, or a related field with 10+ years of relevant
industry experience, OR
o Master’s degree in a related field with 8+ years of experience.
 Experience:
o Minimum 2+ years with a security-focused role or equivalent hands-on
experience implementing secure systems.
o Strong programming skills in C# or a similar modern object-oriented
programming language.

o Familiarity with software QA processes in regulated environments (e.g.,
medical device, FAA, SEC, DoD, Title 21 CFR Part 11) is preferred.
o Experience with low-level embedded serial communication protocols such
as UART, and USB. 
o Strong knowledge of secure coding practices, authentication/authorization
mechanisms, encryption standards, and vulnerability management.
o 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.

Job responsibilities

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 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.

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.