Tool/Automation Engineer- INDIA

Job Description

We are looking for a highly skilled Tool Administrator/Engineer. The Tool Administrator for SaMD Product Development Tools 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 (e.g., FDA, IEC 62304, ISO 13485) 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 (e.g., Jama Connect, ADO, Git), manage roles, permissions, templates, and workflows.

• Access & Security: Integrate tools with SSO (Azure AD, Okta), 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 diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

• Bachelor's degree in Computer Science, Engineering, IT, or related field.

• 3+ years of experience administering software development tools (e.g., Jama, ADO, Jira, Git).

• Experience with Single Sign-On concepts and implementation (SAML, OAuth, OpenID Connect).

• Familiarity with SDLC and ALM principles in regulated environments.

• Working knowledge of compliance frameworks relevant to SaMD (IEC 62304, ISO 13485, FDA CFR Part 11).

• Excellent communication, problem-solving, and documentation skills. - Experience supporting tools in a medical device or health-tech environment.

• Familiarity with test management and requirement traceability for V&V activities.

• Experience writing or supporting tool validation documentation.

Knowledge of DevOps principles and CI/CD pipeline configuration.