PLM 应用工程师（Teamcenter）
PLM Application Engineer (Teamcenter)
负责在受监管的医疗器械环境中，为西门子Teamcenter PLM平台提供专业的内部支持和开发。该职位结合了调试和问题解决的技术专长、软件开发（定制和集成）以及符合规范的技术文档编写能力。
职责
- 在SLA范围内处理L1/L2/L3 Teamcenter事件和服务请求。
- 调查、诊断并解决Teamcenter应用缺陷、服务器错误、工作流失败和数据问题，应用结构化的根本原因分析，并提供具有完整可追溯性的永久性解决方案。
- 使用ITK API、BMIDE业务建模器、Active Workspace客户端定制、Java或C++扩展以及工作流处理器开发，构建定制的Teamcenter解决方案，所有开发均在受控的GxP SDLC下进行。
- 编写和维护受控技术文档，包括系统设计规范（SDS）、验证计划、IQ/OQ/PQ协议、标准操作程序（SOP）、变更控制记录和用户指南，符合ISO 13485和21 CFR Part 11文件控制要求。
- 支持计算机系统验证（CSV）活动，包括安装确认、运行确认和性能确认，确保Teamcenter符合EU MDR 2017/745、ISO 13485和FDA 21 CFR Part 11的要求。
- 管理日常Teamcenter服务器管理：环境健康监控、补丁和升级规划、数据模型迁移。
- 作为Teamcenter专家参与内部和外部审计（FDA、认证机构、ISO），提供系统验证、数据完整性控制和审计追踪完整性的证据。
- 通过正式的变更控制流程管理变更请求，包括影响评估、回归测试，并在生产环境部署前更新验证文档。
- 为工程、质量和法规部门的Teamcenter用户提供最终用户培训，创建用户指南和快速参考材料，并提供持续的帮助台级支持。
我们寻找的人
- 至少3–5年的Teamcenter实际生产环境经验，包括应用支持、调试和开发。
- 精通Teamcenter核心模块（BOM管理、工作流、分类、变更管理、调度器）和Active Workspace；有Polarion使用经验者优先。
查看英文原文
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.
- 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.
About You
- 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.
- 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.
Education/ Qualifications
- Bachelor in Computer Science, Software Engineering, Information Technology. Equivalent professional experience in Teamcenter PLM will be considered.
- Siemens Teamcenter certification is highly desirable. ITIL 4, Prince2/PMP, or GMP/GDP training is a plus. Formal CSV or GAMP 5 training is advantageous.
At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
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About Convatec
Pioneering trusted medical solutions to improve the lives we touch:
Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit:
Originally posted on Himalayas