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.
• Understanding of SDLC DevOps CI/CD change control and system validation concepts.
• Ability to participate in requirements gathering sessions and clearly document outcomes and action items.
• Strong analytical skills with the ability to understand and document business and system processes.
• Experience updating project and validation documentation with attention to detail and traceability.
• Effective written and verbal communication skills with the ability to collaborate cross-functionally.

Technical Skills

• Proficiency with Microsoft Office tools (Word Excel PowerPoint Visio).
• Development proficiency with Java/J2EE HTML JSON REST API XML and other Web 2.0 technologies.
• Working knowledge of SQL and data analysis (queries validation data review).
• Familiarity with Azure Entra ID Shiboleth and other modern infrastructure technologies preferred.
• Familiarity with reporting tools (e.g. Power BI) is a plus.
• Experience documenting process flows functional designs and system configurations.

Experience:

• 3-7 years of experience supporting PLM QMS or other GxP-regulated enterprise systems.
• Hands-on experience with PTC Windchill strongly preferred.
• Exposure to Windchill Bulk Migrator and other data migration tools strongly preferred.
• Exposure to validation activities and regulated system change management.
• Experience supporting Medical Device or Pharmaceutical industry systems strongly preferred.
• Familiarity with systems such as MasterControl Veeva TrackWise or ERP integrations is a plus.

Education:

• BA (or equivalent) in Engineering Computer Science or Business Administration preferred
• Windchill User (aka Fundamentals) a plus
• Windchill User Manufacturing BOM Specialist Certification a plus
• Windchill CAD Integration Specialist Certification a plus
• Windchill Code and Configuration Certification a plus
• Windchill: Rest Services Certification a plus
• PMP or equivalent certification a plus

Qualifications:

Knowledge Skills and Abilities:

• Working knowledge of Windchill PLM configuration and customization in a regulated environment.
• Understanding of SDLC DevOps CI/CD change control and system validation concepts.
• Ability to participate in requirements gathering sessions and clearly document outcomes and action items.
• Strong analytical skills with the ability to understand and document business and system processes.
• Experience updating project and validation documentation with attention to detail and traceability.
• Effective written and verbal communication skills with the ability to collaborate cross-functionally.

Technical Skills:

• Proficiency with Microsoft Office tools (Word Excel PowerPoint Visio).
• Development proficiency with Java/J2EE HTML JSON REST API XML and other Web 2.0 technologies.
• Working knowledge of SQL and data analysis (queries validation data review).
• Familiarity with Azure Entra ID Shiboleth and other modern infrastructure technologies preferred.
• Familiarity with reporting tools (e.g. Power BI) is a plus.
• Experience documenting process flows functional designs and system configurations.

Experience:

• 3-7 years of experience supporting PLM QMS or other GxP-regulated enterprise systems.
• Hands-on experience with PTC Windchill strongly preferred.
• Exposure to Windchill Bulk Migrator and other data migration tools strongly preferred.
• Exposure to validation activities and regulated system change management.
• Experience supporting Medical Device or Pharmaceutical industry systems strongly preferred.
• Familiarity with systems such as MasterControl Veeva TrackWise or ERP integrations is a plus.

Education:

• BA (or equivalent) in Engineering Computer Science or Business Administration preferred
• Windchill User (aka Fundamentals) a plus
• Windchill User Manufacturing BOM Specialist Certification a plus
• Windchill CAD Integration Specialist Certification a plus
• Windchill Code and Configuration Certification a plus
• Windchill: Rest Services Certification a plus

• PMP or equivalent certification a plus.

  As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us at learn more about CooperSurgical and the benefits of becoming a member of our team.

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