Software Tool Validation Engineer (Medical Device Software – Class III) IRC294456

Description

We are seeking a detail-oriented Software Tool Validation Engineer to join our Quality/Engineering team. You will be responsible for the validation of “off-the-shelf” (SOUP/OTSS) and custom software tools used in the design, manufacture, and quality management of Class III medical devices. Your primary mission is to ensure that every tool—from compilers and IDEs to JIRA and automated test frameworks—complies with regulatory requirements and does not compromise the safety or efficacy of our life-saving products.

Requirements

• Education: Bachelor’s degree in Computer Science, Software Engineering, or a related technical field.
• Regulatory Expertise: 3–5+ years of experience in medical device software domain. Experience with Class III products is an advantage
• Standards Mastery: Deep working knowledge of IEC 62304 (Software Lifecycle Processes), ISO 14971 (Risk Management), and ISO 13485 (QMS).
• Technical Proficiency: Experience validating ALM tools (e.g., Jira, Jama, Doors), custom built tools, Libraries, and utilities
o Familiarity with automated testing frameworks.
• Analytical Mindset: Ability to perform “Gap Analysis” on vendor-provided validation packages to ensure they meet internal Quality Management System (QMS) standards.
• Communication: Exceptional technical writing skills with the ability to explain complex validation logic to non-technical auditors.

Job responsibilities

• Validation Strategy: Define and implement the validation strategy for software tools used in the Class III Medical Device Software (SAMD).
• Risk Management: Tool Confidence Level (TCL) assessments and Software Criticality Analysis to determine the depth of validation required based on the tool’s impact on product safety.
• Documentation: Author and execute the full suite of validation deliverables, including:
o Validation Plans and Reports.
o User Requirements Specifications (URS).
o Functional Specifications (FS).
o IQ/OQ/PQ (Installation, Operational, and Performance Qualification) protocols.
o Traceability Matrices (TM).
• Compliance: Ensure all tools meet FDA 21 CFR Part 11 (Electronic Records/Signatures) and Part 820.70(i) requirements, as well as ISO 13485.
• Continuous Monitoring: Manage the “Validation State” of tools through change control, performing impact assessments for software updates, patches, or environment changes.

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.