Tool Engineer - INDIA

Tool Administrator/Engineer

We are looking for a highly skilled Tool Administrator for SaMD Product Development Tools. The Tool Administrator is responsible for the configuration, administration, and user support of digital platforms used throughout the software development lifecycle (SDLC) of Software as a Medical Device (SaMD). This includes tools such as Jama Connect (Requirements and Test Management), Azure DevOps (Work Item Tracking, Source Control, Build/Release Pipelines), and others as applicable. The role ensures these tools align with regulatory requirements and supports system access via Single Sign-On (SSO) integration.

Compensation: $13/hr to $16/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401K retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Key Responsibilities:

• Tool Administration: Configure and maintain SDLC/ALM tools, manage roles, permissions, templates, and workflows.
• Access & Security: Integrate tools with SSO, enforce secure authentication and access controls.
• Compliance & Validation: Support tool validation per ISO 13485 and 21 CFR Part 11, maintain audit-ready documentation and change logs.
• User Enablement: Provide tool support, training, and onboarding; handle inquiries and tickets.
• Process Integration: Align tools with SaMD processes including risk management, traceability, and design control.
• Monitoring & Optimization: Track tool performance, usage, and updates; recommend improvements for usability and compliance.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please contact Human Resources.