Validation Engineer

Overview

The Validation Engineer will report to the Sustaining Engineering Manager and will focus on life cycle management for the Medical Division's existing products. This position will evaluate manufacturing processes and perform validation tests to ensure compliance with company requirements and industry standards.

This is a highly strategic role within the ITW Medical business and provides a path for driving meaningful impact within the business.

Responsibilities

• Develops and executes validation protocols (IQ, OQ, PQ) for equipment, processes, and products.
• Establishes validation standards and develops performance testing and quality control measures. Develop test procedures that produces validation data.
• Analyzes and interprets validation data to identify trends, anomalies, and areas for improvement, utilizing statistical techniques.
• Ensures validation activities comply with regulatory requirements and industry standards.
• Independently tests, analyzes and solves technical problems.
• Performs risk assessments and develops mitigation strategies related to validation activities.
• Works with customers to understand requirements and translates into validation protocols and specifications. Reviews and approves validation deliverables from customers and third-party service providers.
• Conducts FMEAs and risk analysis as a part of the design control process.
• Identifies root causes of production problems. Identifies nonconformities of product or process standards and offers recommendations for resolving deviations.
• Provides technical support to the production team on product specifications and requirements.
• Works closely with Engineers, Customers, Sales and Manufacturing regarding engineering change management.

Qualifications

Physical Demands

Compensation Information

Pay Transparency

This compensation range is provided as a reasonable estimate of the current salary range for this role. Compensation depends on relevant experience and / or education, specific skills, market level, other job-related factors, geographic location, and other factors as applicable by law. As applicable this role will also receive overtime compensation and may be eligible for shift premium compensation.

Pay Range : $85,000-110,000

Benefits

Benefits for this role can be seen by visiting www.itwemployee.com. In addition, employees can qualify for vacation, sick, and holiday compensation benefits.

Vacation - up to 80 hours of time within first year

Sick - up to 40 hours of time within first year

Floating Holiday - up to 8 hours of time within first year

Holiday - 10 paid holidays per year, these holidays are selected by the Division

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