PLM Application Engineer – Teamcenter

This is a fully remote position, open to applicants in India.

📋 Description

• Address L1/L2/L3 Teamcenter incidents and service requests within the agreed SLA.

• Examine, diagnose, and resolve defects in the Teamcenter application, server errors, workflow breakdowns, and data discrepancies, employing structured root-cause analysis and delivering permanent solutions with complete traceability.

• Create tailored Teamcenter solutions utilizing ITK APIs, BMIDE business modeling, client-side customization of the Active Workspace, Java or C++ extensions, and workflow handler development, all within a regulated GxP SDLC.

• Write and manage controlled technical documentation, including System Design Specifications (SDS), Validation Plans, IQ/OQ/PQ protocols, SOPs, change control records, and user manuals, ensuring adherence to ISO 13485 and 21 CFR Part 11 document control standards.

• Assist with Computer System Validation (CSV) activities—covering installation qualification, operational qualification, and performance qualification—to maintain Teamcenter in a validated condition in compliance with EU MDR 2017/745, ISO 13485, and FDA 21 CFR Part 11.

• Oversee daily Teamcenter server administration, including monitoring environment health, planning patches and upgrades, and executing data model migrations.

• Engage in internal and external audits (FDA, Notified Body, ISO) as the Teamcenter Subject Matter Expert (SME), supplying proof of system validation, data integrity measures, and the completeness of audit trails.

• Process change requests via the formal change control procedure, which includes impact assessments, regression testing, and updating validation documentation prior to implementation in the production environment.

• Provide end-user training, develop user guides and quick-reference materials, and extend ongoing helpdesk support to Teamcenter users across engineering, quality, and regulatory sectors.

⛳️ Requirements

• A minimum of 3–5 years of practical Teamcenter experience in a production setting.

• Expertise in core Teamcenter modules (BOM Management, Workflow, Classification, Change Management, Dispatcher) and Active Workspace; familiarity with Polarion is advantageous.

• Practical development experience with Teamcenter ITK (C/C++ or Java), BMIDE data model configuration, workflow handler programming, and client-side customization of Active Workspace (AWC).

• Knowledge of medical device regulatory standards: 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 capabilities, with the skill to trace intricate multi-tier Teamcenter issues through server logs, database queries, and client-side actions.

• Exceptional written and verbal communication skills; capable of producing clear technical documentation and conveying 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 provide end-user training, create user guides and quick-reference materials, and deliver ongoing helpdesk support in a regulated medical device context.

🏝️ Benefits

• Health insurance

• Flexible work arrangements

• Professional development opportunities