Manufacturing Engineer Medical Devices (IQ/OQ/PQ Focus)

Title: Manufacturing Engineer Medical Devices (IQ/OQ/PQ Focus)

Location: Gainesville, FL (On-site)

Duration: Long Term Contract

Position Summary:

Our client is seeking a highly skilled Manufacturing Engineer with a strong background in the medical device industry and extensive experience in IQ/OQ/PQ validation activities. The successful candidate will ensure that manufacturing processes meet regulatory requirements, improve efficiency, and maintain the highest quality standards.

Key Responsibilities:

• Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment and processes.
• Develop and maintain process validation protocols, reports, and associated documentation in compliance with ISO 13485, FDA 21 CFR Part 11, and GMP requirements.
• Collaborate with Quality, R&D, and Production teams to ensure smooth transfer of new products into manufacturing.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for process deviations.
• Optimize manufacturing processes to improve yield, reduce cost, and maintain compliance.
• Support equipment selection, procurement, and installation.
• Ensure adherence to environmental, health, and safety (EHS) guidelines.

Qualifications:

• Bachelor s degree in Mechanical, Manufacturing, Industrial Engineering, or related field.
• Experience: 6-8 years
• 6+ years of experience in manufacturing engineering within the medical device industry.
• Proven experience with IQ/OQ/PQ execution and documentation.
• Strong understanding of validation requirements under FDA and ISO regulations.
• Excellent problem-solving and documentation skills.