Validation Engineer 3 (contingent)

Joulé; Littleton (CO); On-site; Full time

Job summary

A leading company in medical technology is seeking a Validation Engineer 3 to support a critical business unit. This role involves leading validation projects and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in validation engineering within the medical device industry and a strong educational background in engineering.

Qualifications

• Minimum 4+ years of validation and quality engineering experience in medical devices.
• Experience with IQ/OQ/PQ, process validation, and test method validation.

Responsibilities

• Lead validation projects, including authoring and executing Validation Master Plans.
• Collaborate to maintain compliance with FDA, ISO 13485, and GMP requirements.

Skills

Validation Engineering

Quality Engineering

Risk Management

Root Cause Analysis

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Electrical Engineering

Bachelor’s degree in Biomedical Engineering

Tools

FMEA

Job description

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Job Title:

Validation Engineer 3

Location:

Lakewood, CO

Compensation:

$53– $66.50 per hour

Type:

9 month contract

Overview:

Join a globally recognized leader in medical technology that specializes in life-saving devices used in blood donation and plasma separation. This Validation & Quality Engineer 3 role supports a high-impact, stable business unit working on a new product entering an entirely new market for the company. Be part of a mission-driven team contributing to innovation and playing a critical role in healthcare worldwide.

Responsibilities:

• Lead validation projects, including authoring and executing Validation Master Plans (VMP), Installation (IQ), Operational (OQ), and Performance Qualifications (PQ)
• Execute and document test method validation protocols, conduct statistical analysis, and ensure compliance with internal procedures
• Support validation activities from approved suppliers, ensuring records meet regulatory and corporate standards
• Perform periodic reviews of automated equipment, computerized systems, and test instruments
• Evaluate and adapt technical solutions for complex validation and quality engineering problems
• Serve as project lead on high-complexity projects, overseeing execution
• Conduct root cause analyses and lead CAPA/NC resolution efforts
• Collaborate across functions to maintain compliance with FDA, ISO 13485, and GMP requirements

Requirements:

• Minimum 4+ years of validation and quality engineering experience in the medical device industry
• Experience with IQ/OQ/PQ, process validation, and test method validation
• Knowledge of FDA regulations, ISO 13485, GMP, and validation documentation
• Proficiency with risk management tools such as FMEA
• Strong background in CAPA and NC processes, including investigative and corrective actions
• Technical expertise in fluids engineering, mechanical/chemical systems, or cellular biology
• Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or a relevant scientific field

Additional Information:

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Quality Assurance