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Convatec

PLM Application Engineer (Teamcenter)

УдалённоIndia только
Опубликовано
Опыт
Мидл
Занятость
Полная занятость
Размер компании
Крупная
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Коротко по делу

Teamcenter Application Engineer needed for a regulated medical device environment. Requires 3-5 years of Teamcenter experience, including support, debugging, and development using ITK APIs, BMIDE, and Active Workspace. Must understand medical device regulatory requirements (FDA 21 CFR Part 11, ISO 13485, EU MDR).

Ключевые навыки

TeamcenterITK APIsBMIDE

Обязательные навыки

Active WorkspaceJavaC++workflow handler developmentBOM ManagementWorkflowClassificationChange ManagementDispatcherPolarion

Желательные навыки

Teamcenter deployment on on-premise or hybrid infrastructure (AWS, Azure)Siemens Teamcenter certificationITIL 4Prince2/PMPGMP/GDP trainingGAMP 5 training

Обязательные языки

English

Чем предстоит заниматься

  • 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.

Что требуется

  • Minimum of 3–5 years of hands-on Teamcenter experience in a production environment, including application support, debugging, and development.
  • 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.
  • Ability to deliver end-user training, create user guides and quick-reference materials, and provide ongoing helpdesk support in a regulated medical device environment.
  • Bachelor in Computer Science, Software Engineering, Information Technology.
  • Equivalent professional experience in Teamcenter PLM will be considered.
  • Formal CSV or GAMP 5 training is advantageous.

Преимущества

  • Pioneering trusted medical solutions to improve the lives we touch.
  • Help us bring our Forever Caring promise to life.

UK medical products and technologies company

HealthcareКрупнаяconvatec.com
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