29 Aug
|
Convatec
|
Haryana
About Convatec
The Teamcenter Application Engineer provides dedicated in-house support and development for the Siemens Teamcenter PLM platform within a regulated medical device environment. 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.- 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: environment 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-reference materials, and provide ongoing helpdesk-level support to Teamcenter users across engineering, quality, and regulatory functions.
About You- Proficiency in Teamcenter core modules (BOM Management,
📌 Plm Application Engineer (Haryana)
🏢 Convatec
📍 Haryana