PLM Windchill SME – CSV & Validation Expert

Intellectt Inc; United States; On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement Plan

Paid Time Off as per law

Job summary

Intellectt Inc. seeks a PLM Windchill SME with expertise in PCM, eBOM, and mBOM to manage product structures and changes in a regulated environment. You will develop test scripts, perform UAT, and prepare CSV documentation with risk assessments and traceability matrices.

Experience in FDA/21 CFR Part 11, ISO 13485, and GxP is required, with emphasis on quality systems and validation compliance in medical devices or life sciences.

Qualifications

• 5+ years in PLM/Windchill engineering environments.
• Hands-on Windchill, PCM, eBOM and mBOM experience.
• Strong change control and configuration management knowledge.
• Experience with CSV, validation planning, and validation reports.
• Familiarity with FDA 21 CFR Part 11, ISO 13485 and GxP requirements.

Responsibilities

• Support Windchill PLM/PCM functionality, configuration, and enhancements.
• Manage product structures, BOMs, document control, and engineering changes.
• Develop and execute test scripts, test cases, and UAT.
• Prepare CSV documentation including requirements, risk assessments, traceability matrices, and validation reports.
• Support change control, compliance, audit readiness, and troubleshooting.

Skills

PLM/Windchill

PCM

eBOM & mBOM

Engineering change

CSV & validation docs

SDLC

Job description

Intellectt Inc. seeks a PLM Windchill SME with expertise in PCM, eBOM, and mBOM to manage product structures and changes in a regulated environment. You will develop test scripts, perform UAT, and prepare CSV documentation with risk assessments and traceability matrices.

Experience in FDA/21 CFR Part 11, ISO 13485, and GxP is required, with emphasis on quality systems and validation compliance in medical devices or life sciences.