Sr Process Engineer - Medical Device

Job Description

Job Title : Sr Process Engineer – Medical Device

Job Location : Irvine, California (Fully onsite)

Type : W2 contract

Duration : 6 months

Job Description : Must-Have :

Med device experience, particularly in process / manufacturing or process development

Process Validation experience (PC, IQ, OQ, PQ); Hands-on experience designing fixturing, optimizing line layout / capacity

Manufacturing knowledge with polymers, metals, and Knowledge of processes such as bonding, coating, cleaning, heat set, etc.

Education Required : BS / MS in Engineering, Years’ Experience Required : MS (2yrs +), BS (4yrs +)

Responsibilities may include the following, and other duties may be assigned.

Provides technical and sustaining engineering support in a manufacturing area.

Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques, as well as production yields for existing products.

Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.

Reviews product development requirements for compatibility with processing methods to determine costs and schedules.

Interacts with product design and development personnel to ensure that processes and designs are compatible.

May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development, and / or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations.

This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation, and assessment of inputs, outputs, and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques, including the measurement systems. Ensures processes and procedures are in compliance with regulations.