Description :

Tools Engineer (SaMD Product Development)

Experience : 3+ Years

Duration : 6-Month Contract-to-Hire (CTH)

Role Summary :

We are seeking a technically proficient Tools Engineer to manage and optimize the digital ecosystem powering our Software as a Medical Device (SaMD) development lifecycle. In this role, you will be responsible for the end-to-end administration, configuration, and user support of critical SDLC platforms, including Jama Connect and Azure DevOps (ADO). You will ensure these tools are not only performant but also strictly compliant with global medical device regulations such as IEC 62304, ISO 13485, and FDA CFR Part 11. A core focus of the role involves managing secure system access through SSO (SAML, OAuth) and maintaining the integrity of requirements traceability and test management for V&V activities. This position offers a unique opportunity to bridge the gap between DevOps efficiency and rigorous health-tech compliance in a high-impact, hybrid environment.

Responsibilities :

- Toolchain Administration : Lead the configuration, maintenance, and administration of core SDLC tools, specifically Jama Connect (Requirements/Test Management) and Azure DevOps (Work Item Tracking, Source Control).

- Regulatory Alignment : Ensure all tool configurations and workflows strictly adhere to SaMD regulatory frameworks, including FDA 21 CFR Part 11, IEC 62304, and ISO 13485.

- Identity & Access Management : Implement and support Single Sign-On (SSO) integrations using SAML, OAuth, and OpenID Connect to ensure secure and seamless user authentication.

- V&V Support : Facilitate Verification and Validation (V&V) activities by maintaining end-to-end requirement traceability and automated test management workflows.

- Pipeline Management : Support and configure CI/CD build and release pipelines within Azure DevOps to streamline the SaMD delivery process.

- Validation Documentation : Author and maintain tool validation documentation (IQ/OQ/PQ) to ensure the software development environment remains in a validated state.

- User Support & Onboarding : Provide expert-level technical support and training to engineering teams on tool utilization and best practices.

- Source Control Governance : Manage repository structures, branching strategies, and access permissions within Git and ADO.

- Compliance Auditing : Participate in internal and external audits by providing evidence of tool validation, audit trails, and access control logs.

- Process Automation : Identify opportunities to automate manual tool administration tasks and improve overall SDLC efficiency through DevOps principles.

Technical Requirements :

- Tooling Expertise : 3+ years of professional experience administering software development platforms such as Jama, ADO, Jira, and Git.

- Security Literacy : Strong understanding of SSO concepts and hands-on experience with SAML, OAuth, and OpenID Connect implementations.

- Compliance Knowledge : Working knowledge of IEC 62304 (Medical device software lifecycle), ISO 13485 (Quality management), and FDA CFR Part 11 (Electronic records).

- Platform Management : Proven ability to configure complex work-item tracking and requirements-management hierarchies.

- Education : Bachelors degree in Computer Science, Software Engineering, or a related field.

Preferred Skills :

- Health-Tech Background : Prior experience supporting development tools within a medical device or regulated healthcare environment.

- Traceability Mastery : Familiarity with creating automated traceability matrices across disparate tools for regulatory submission.

- DevOps Proficiency : Experience with infrastructure-as-code or scripting for tool automation.

- Documentation Excellence : Strong technical writing skills for creating validation protocols and standard operating procedures (SOPs).

- Local Proximity : Candidates must be local to Hyderabad or committed to relocation for the onsite hybrid requirement upon conversion.