VALIDATION ENGINEER

Staftonic LLC; Boston (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company specializing in recruiting top-tier talent is looking for a Validation Engineer in Boston, MA. This role involves leading the IQ/OQ/PQ processes in medical equipment manufacturing, ensuring compliance with FDA and ISO standards while driving quality improvements in a regulated environment.

Qualifications

• 5+ years in medical device engineering.
• 3+ years in QA/validation.
• Strong experience with IQ/OQ/PQ.

Responsibilities

• Lead IQ/OQ/PQ processes and support equipment qualifications.
• Develop protocols and manage change controls.
• Ensure compliance with FDA, ISO 13485 and risk management.

Skills

Medical device engineering

QA/validation

Process validation

ISO 13485

FDA compliance

GD&T

Communication

Project management

Education

Bachelor’s in Engineering, Science or related field

Master’s degree (preferred)

Job description

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Strategic Talent Partner connecting high-performing professionals with industry-leading organizations. Specializing in recruiting top-tier talent…

• Validation Engineer

Long Term

Role

• Seeking a Validation Engineer to lead IQ / OQ / PQ processes, support equipment qualifications, and ensure compliance with FDA , ISO 13485 , and risk management standards . You’ll develop protocols, manage change controls, and drive quality improvements in a regulated environment.

Key Skills &

• 5+ years in medical device engineering
• 3+ years in QA / validation
• Strong experience with IQ / OQ / PQ , process validation
• Knowledge of ISO 13485 , FDA 21 CFR Part 820 , and GD&T
• Excellent communication and project management skills
• Bachelor’s in Engineering, Science, or related field (Master’s preferred)

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Medical Equipment Manufacturing

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Validation Engineer • Boston, MA, United States