Medical Device Process Engineer II: Validation & CI

Apex Systems; Riverview (FL); On-site; USD 89,048,000 - 100,289,000; Part time

Job summary

Apex Systems is seeking a Process Engineer II for a contract role in Riverview, FL to support medical device manufacturing, optimization, and qualification activities.

The position requires hands-on experience with IQ/OQ/PQ, SPC, and GMP, plus project management skills to drive validation and transfer projects across production lines.

You will collaborate with suppliers, maintain documentation in the QMS, and ensure compliance with FDA regulations.

Qualifications

• Bachelor’s degree in a related engineering discipline is required.
• 2+ years in a manufacturing environment, preferably medical device industry.
• Experience with IQ/OQ/PQ, GMP, and FDA regulations is preferred.

Responsibilities

• Analyze and optimize manufacturing processes and equipment for productivity and quality.
• Lead validation activities (IQ/OQ/PQ) and document protocols.
• Coordinate suppliers and cross-functional teams to support equipment commissioning and transfer.

Skills

Process engineering

Statistical analysis

Project management

Documentation

Education

Bachelor's degree in Mechanical/Electrical/Manufacturing Engineering or related field

Tools

AutoCAD

MS Office

Minitab

Job description

Apex Systems is seeking a Process Engineer II for a contract role in Riverview, FL to support medical device manufacturing, optimization, and qualification activities.

The position requires hands-on experience with IQ/OQ/PQ, SPC, and GMP, plus project management skills to drive validation and transfer projects across production lines.

You will collaborate with suppliers, maintain documentation in the QMS, and ensure compliance with FDA regulations.