Sr Manufacturing Engineer

Out of State candidate will have to relocate on their own to TX in 2-3 weeks time.

Pay Rate- $55/hr W2

Contract Term: 12 months with possible extension.

An individual contributor with responsibility in our technical functions to advance existing technology. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

• 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 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.

• 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
• a Computer System Validation Engineer III

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

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