Job Title - Sr Manufacturing Engineer – Medical Devices

Job Location - Santa Ana, California (Fully onsite)

Type: W2 contract

Skills Required:

1. Medical Device experience is mandatory.

2. Perform feasibility studies that explore new catheter assembly process technologies

3. Generate and execute plans for equipment qualification and process validation.

4. Use of appropriate Six Sigma methodologies such as Design of Experiments (DOEs), Gage R&R, and other statistical tools as necessary to reduce variation in process development.

Education Required: Bs minimum Mechanical Engineering or Bio Engineering, Years’ Experience Required: 4 minimum preferred in Medical Device Industry

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 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. Inspection and test requirements may be incorporated 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. Ensure processes and procedures are following regulations.