Lead PLM Application Engineer

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

📋 Description

• Lead and oversee a Teamcenter support team consisting of three members, managing workload distribution, establishing priorities, monitoring team performance, and ensuring the delivery of high-quality services in accordance with established SLAs.

• Serve as the primary escalation point for L1/L2/L3 Teamcenter incidents and service requests, conducting investigations, diagnosing issues, and coordinating the resolution of complex application defects, server errors, workflow failures, and data problems through structured root-cause analysis and permanent solutions.

• Direct the design and governance of tailored Teamcenter solutions utilizing ITK APIs, BMIDE business modeling, Active Workspace client-side customization, Java or C++ extensions, and workflow handler development, while mentoring team members and upholding a controlled GxP SDLC.

• Create and maintain controlled technical documentation such as System Design Specifications (SDS), Validation Plans, IQ/OQ/PQ protocols, SOPs, change control records, and user guides, ensuring compliance with ISO 13485 and 21 CFR Part 11 documentation requirements.

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

• Supervise daily Teamcenter service operations and server administration, which involves environment health monitoring, planning for patches and upgrades, data model migrations, capacity planning, and coordinating team activities.

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

• Manage change requests through the official change control process, encompassing impact assessments, regression testing, and updating validation documentation before deployment in the production environment.

• Mentor and develop the Teamcenter support team, establish knowledge-sharing practices, and ensure the effective delivery of end-user training, user guides, and ongoing support across engineering, quality, and regulatory functions.

⛳️ Requirements

• A minimum of 10+ years of practical Teamcenter experience in a production setting.

• Proficient in core Teamcenter modules (BOM Management, Workflow, Classification, Change Management, Dispatcher) and Active Workspace; experience with Polarion is preferred.

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

• Knowledge 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 capabilities, with the proficiency to trace complex multi-tier Teamcenter issues across server logs, database queries, and client-side behaviors.

• Excellent written and verbal communication skills, capable of leading a small technical team, influencing stakeholders, producing clear technical documentation, and presenting solutions to non-technical stakeholders including QA, Regulatory Affairs, and senior management.

• Experience with Teamcenter deployment on on-premises or hybrid infrastructures (AWS, Azure) is advantageous.

• Proven ability to lead, coach, and develop a small support team while driving service enhancements, creating user guidance materials, and delivering effective support in a regulated medical device environment.

🏝️ Benefits

• Health insurance

• Flexible working hours

• Professional development opportunities