Validation Engineer

Job Description

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.

Roles And 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

• Minimum of 5 years injection molding in a high-volume manufacturing environment required, preferably in medical-device manufacturing.
• Bachelor’s degrees in engineering or related field required.
• Demonstrates comprehensive knowledge of Engineering & Statistical principles and their application in solving complex problems.
• In-depth knowledge of production processes, parameters, and standards.
• Possesses an understanding of DFMEA & PFMEA methodology and approach, understands part design layout and GD&T.
• Excellent leadership, collaboration, and both written and verbal communication skills.
• Team-oriented individual who thrives in a fast-paced environment.
• Possess the ability to train, mentor and coach others to solve technical problems.
  
  

Physical Demands

• While performing the duties of this job, the employee is regularly required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is frequently required to reach with hands and arms, stoop, kneel, or crawl; and talk or hear.
• The employee must frequently lift and move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
  
  

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