Pioneering trusted medical solutions to improve the lives we touch
PLM Application Engineer – Teamcenter
Location
India
Posted
3 days ago
Salary
0
Seniority
Senior
Job Description
PLM Application Engineer – Teamcenter
Convatec
• 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: 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 environment • 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
Job Requirements
- Minimum of 3–5 years of hands-on Teamcenter experience in a production environment
- Proficiency in Teamcenter core modules (BOM Management, Workflow, Classification, Change Management, Dispatcher) and Active Workspace; experience with Polarion
- Hands-on development experience with Teamcenter ITK (C/C++ or Java), BMIDE data model configuration, workflow handler programming, and Active Workspace (AWC) client-side customization
- Understanding of medical device regulatory requirements: FDA 21 CFR Part 11 (electronic records/signatures), ISO 13485 (QMS), EU MDR 2017/745, IEC 62304 (medical device software lifecycle), and ISO 14971 (risk management)
- Strong analytical and debugging skills with the ability to trace complex multi-tier Teamcenter issues across server logs, database queries, and client-side behavior
- Excellent written and verbal communication skills; able to produce clear technical documentation and present solutions to non-technical stakeholders including QA, Regulatory Affairs, and senior management
- Experience with Teamcenter deployment on on-premise or hybrid infrastructure (AWS, Azure) is a plus
- Ability to deliver end-user training, create user guides and quick-reference materials, and provide ongoing helpdesk support in a regulated medical device environment.
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
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