04 Oct
|
Convatec
|
Hyderabad
04 Oct
Convatec
Hyderabad
The Teamcenter Application Engineer provides dedicated in-house support and development for the Siemens Teamcenter PLM platform within a regulated medical device setting. This role combines hands-on technical expertise in debugging and issue resolution, software development (customization and integration), and the creation of compliant technical documentation.
About Role
Resolve L1/L2/L3 Teamcenter incidents and service requests within SLA.
Investigate, diagnose, and resolve Teamcenter application defects, server errors, workflow failures, and data issues, applying structured root-cause analysis and providing permanent fixes with full traceability.
Develop custom Teamcenter solutions using ITK APIs, BMIDE business modeller, Active Workspace client-side customization, Java or C++ extensions, and workflow handler development, all under a controlled GxP SDLC.
Author and maintain controlled technical documents including System Design Specifications (SDS), Validation Plans, IQ/OQ/PQ protocols, SOPs, change control records,
and user guides in compliance with ISO 13485 and 21 CFR Part 11 document control requirements.
Support Computer System Validation (CSV) activities – including installation qualification, operational qualification, and performance qualification – to keep Teamcenter in a validated state aligned with EU MDR 2017/745, ISO 13485, and FDA 21 CFR Part 11.
Manage day-to-day Teamcenter server administration: setting health monitoring, patch and upgrade planning, data model migrations.
Participate in internal and external audits (FDA, Notified Body, ISO) as the Teamcenter SME, providing evidence of system validation, data integrity controls, and audit trail completeness.
Manage change requests through the formal change control process, including impact assessments, regression testing, and updating validation documentation prior to deployment in the production workplace.
Deliver end-user training, create user guides and quick-referenc
📌 Plm Application Engineer Hyderabad
🏢 Convatec
📍 Hyderabad