Senior Technical Architect & Developer

The Windchill PLM Technical Architect & Developer supports the design, configuration, development, and ongoing optimization of the Windchill Product Lifecycle Management (PLM) platform within a regulated medical device environment. This role focuses on translating approved business and functional requirements into technical solutions, supporting system enhancements, integrations, and validation activities under the guidance of senior architects and product owners.

The position is hands-on and execution-focused, contributing to project delivery, system stability, and continuous improvement while ensuring compliance with regulatory and quality standards.

The Windchill PLM Technical Architect & Developer works closely with Business Analysts, Quality, Regulatory Affairs, Engineering and other business stakeholders to support the implementation, enhancement, and maintenance of the Windchill PLM solution. This role participates in requirements gathering, functional design, system configuration, and development, and supports validation documentation and testing activities required for regulated system changes.

The role collaborates within cross-functional project teams and supports global users while following established architectural standards, governance processes, and validation frameworks.

Key Responsibilities:

Technical Design & Development

* Configure and develop Windchill PLM solutions, including workflows, lifecycle states, attributes, business rules, and integrations.

* Translate approved functional and business requirements into technical designs and system configurations.

* Support integrations between Windchill and upstream/downstream systems (e.g., ERP, QMS, RIM) under established architectural guidance.

* Assist in troubleshooting and resolving system defects, configuration issues, and data inconsistencies.

Business Requirements & Functional Design

* Participate in Business Requirements solicitation sessions with business stakeholders, documenting system needs and constraints.

* Support and co-lead Functional Process Definition workshops to define future-state workflows and system behavior.

* Collaborate with Business Analysts to review, refine, and validate requirements, use cases, and functional specifications.

* Ensure requirements are traceable through design, development, testing, and validation deliverables.

Validation & Compliance Support

* Contribute to validation documentation updates, including URS, FRS, risk assessments, traceability matrices, Configuration Specifications, Technical Specifications, and validation plans.

* Perform Code Review for all code written for use in robots, listeners, integrations, etc.

* Execute and document test cases (IQ/OQ/PQ/UAT) in accordance with IT Change Control and validation procedures.

* Support audit readiness by ensuring system changes are properly documented and compliant with internal procedures.

* Adhere to regulatory standards including 21 CFR Part 11, 21 CFR Part 820, ISO 13485, and applicable global regulations.

Deployment & Change Support

* Support system deployments, configuration migrations, and release activities across environments.

* Assist with change impact assessments, release notes, and deployment documentation.

* Coordinate with infrastructure, QA, and business teams to ensure smooth rollout of system changes.

Documentation & Training

* Create and update system documentation, configuration specifications, SOPs, and Work Instructions related to Windchill functionality.

* Support development and maintenance of end-user training materials and reference guides.

* Assist with end-user onboarding, system demos, and post-deployment support activities.

Continuous Improvement & Operations

* Identify opportunities to improve system performance, usability, and process efficiency.

* Support routine system maintenance, periodic reviews, and defect remediation.

* Escalate complex technical issues to senior architects as appropriate, providing background analysis and recommendations.

Travel:

Travel up to 25% may be required.

Qualifications

Knowledge, Skills and Abilities:

* Working knowledge of Windchill PLM configuration and customization in a regulated environment.

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