Remote job
Lead PLM Application Engineer
Convatec
via Himalayas
Job description
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 more than 10,000 colleagues, we provide our 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 and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec ’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com
The Lead Teamcenter Application Engineer provides technical leadership, in-house support, and development for the Siemens Teamcenter PLM platform within a regulated medical device environment. This role combines hands-on expertise in debugging and issue resolution, software development (customisation and integration), and the creation of compliant technical documentation, while also leading and coordinating a team of three Teamcenter support professionals.
About Role
- Lead and manage a Teamcenter support team of three, allocating workload, setting priorities, monitoring performance, and ensuring high-quality service delivery against agreed SLAs.
- Act as the lead escalation point for L1/L2/L3 Teamcenter incidents and service requests, investigating, diagnosing, and coordinating the resolution of complex application defects, server errors, workflow failures, and data issues with structured root-cause analysis and permanent fixes.
- Lead the design and governance of custom Teamcenter solutions using ITK APIs, BMIDE business modeller, Active Workspace client-side customisation, Java or C++ extensions, and workflow handler development, while mentoring team members and maintaining 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.
- Oversee day-to-day Teamcenter service operations and server administration, including environment health monitoring, patch and upgrade planning, data model migrations, capacity planning, and coordination of team activities.
- 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.
- Coach and develop the Teamcenter support team, establish knowledge-sharing practices, and ensure end-user training, user guides, and ongoing support are delivered effectively across engineering, quality, and regulatory functions.
About You
- Minimum of 10+ years of hands-on Teamcenter experience in a production environment, including application support, debugging, development, and team leadership.
- 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, with the ability to lead a small technical team, influence stakeholders, produce clear technical documentation, and present solutions to non-technical stakeholders including QA, Regulatory Affairs, and senior management.
- Experience with Teamcenter deployment on on-premises or hybrid infrastructure (AWS, Azure) is a plus.
- Demonstrated ability to lead, coach, and develop a small support team, while driving service improvements, creating user guidance materials, and providing effective support in a regulated medical device environment.
Education/Qualifications
- A Bachelor’s or Master’s degree in Computer Science, Software Engineering, Info
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