PLM Windchill SME Consultant – CSV Support

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

Job Title: PLM Windchill SME Consultant – CSV Support

Job Summary:

Seeking an experienced PTC Windchill SME with strong knowledge of PLM, Product Configuration Management (PCM), product structures, eBOMs, mBOMs, and engineering change management. The candidate should have hands-on experience with system testing, UAT, and Computer System Validation (CSV) in a regulated medical device or life sciences environment.

Key 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.

Required Skills:

• 5+ years of PLM/Windchill experience.
• Strong hands-on experience with PTC Windchill, PCM, eBOM, and mBOM.
• Knowledge of engineering change management and configuration control.
• Experience in CSV, SDLC, system testing, and validation documentation.
• Knowledge of FDA requirements, 21 CFR Part 11, ISO 13485, and GxP.
• Experience in medical devices, pharmaceuticals, or life sciences.

Benefits:

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements

Health Insurance:

Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:

A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):

No PTO other than that required by applicable state and local laws

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.