Sr Manufacturing Engineer - Exempt

Join our dynamic team in Fort Worth, TX, where innovation meets excellence. As a Senior Manufacturing Engineer, you will play a pivotal role in advancing existing technology and ensuring the highest standards of product quality in a highly regulated field.

Must Have

• Experience in equipment IQ
• Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
• Process Validation Lifecycle (from process characterization, operational qualification to performance qualification)
• Preferred experience in DOE (with Minitab)

Other Skills

• Computer and software validation CSV
• SOP Development
• Change control of Medical Devices

Responsibilities

Responsibilities may include the following and other duties may be assigned:

• Designs manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Designs arrangement of machines within plant facilities to ensure the most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.

Top 3 Technical Skills Required

• Project management
• Validation and qualification
• System integration and manufacturing process design

Education Required

Mechanical Engineering degree; open to other disciplines as long as candidates have a strong background in manufacturing in a highly regulated field.

Years of Experience Required

5 years

Work Schedule

40 hours per week, 100% onsite

Product Line Supported

Midas Rex product (Tools/Capital)