Senior Validation Engineer - Medical Devices & Sterility

Interactive Resources; Gainesville (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Interactive Resources is seeking a Quality Validation Engineer to lead validation protocols for medical devices in a regulated environment. You will develop and execute IQ/OQ/PQ, support risk-based validation strategies, and prepare comprehensive technical documentation.

Responsibilities include ensuring compliance with FDA/ISO quality systems, supporting sterility, bioburden, biocompatibility, and analytical testing, and driving continuous improvement across manufacturing processes.

Qualifications

• The candidate holds a bachelor's degree in engineering or related technical field with 5+ years in medical devices.
• Experience with IQ, OQ, PQ and other qualification methodologies.
• Ability to develop and execute validation protocols and test methods.
• Understanding of risk-based validation and FMEA methods.
• Familiarity with FDA and ISO quality system requirements.

Responsibilities

• Develop and execute validation protocols for medical device processes.
• Support risk-based validation strategies and document results.
• Prepare technical documentation for validation activities.
• Maintain compliance with quality systems and regulatory requirements.
• Assist with device cleanliness, sterility, biocompatibility, and analytical testing.

Skills

Validation

Verification

Quality engineering

Manufacturing engineering

Risk-based validation

FMEA

pFMEA

FDA/ISO knowledge

Data analysis

Measurement systems

Process validation

Documentation

Education

Bachelor's degree in Engineering or related

Job description

Interactive Resources is seeking a Quality Validation Engineer to lead validation protocols for medical devices in a regulated environment. You will develop and execute IQ/OQ/PQ, support risk-based validation strategies, and prepare comprehensive technical documentation.

Responsibilities include ensuring compliance with FDA/ISO quality systems, supporting sterility, bioburden, biocompatibility, and analytical testing, and driving continuous improvement across manufacturing processes.