Convatec logo
Convatec

Pioneering trusted medical solutions to improve the lives we touch

Lead PLM Application Engineer

Application EngineerApplication EngineerFull TimeRemoteSeniorTeam 5,001-10,000Since 1978H1B SponsorCompany SiteLinkedIn

Location

India

Posted

3 days ago

Salary

0

Seniority

Senior

Bachelor Degree10 yrs expEnglishAWSAzureJavaSDLC

Job Description

Lead PLM Application Engineer

Convatec

• 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.

Job Requirements

  • Minimum of 10+ 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, 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.

Benefits

  • Health insurance
  • Flexible working hours
  • Professional development opportunities

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