Manufacturing Engineer

Job Title: Manufacturing Engineer

Job Location: Irvine, CA

Job Type: Contract

Job Overview:

Pay Range: $54.18hr - $59.18hr

Responsibilities:

• Expert knowledge of Installation, Operational, and Performance Qualification (IQ, OQ, PQ) of complex systems and equipment.
• Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish a standard production rate and improve efficiency.
• Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
• Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
• Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
• Please prepare charts, graphs, and diagrams to illustrate the workflow, routing, floor layouts, material handling, and machine utilization.
• Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
• Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
• Evaluate data and write reports to validate or indicate deviations from existing standards.

• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Ability to make sketches, engineering drawings and common computations.
• Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

• Hands-on experience with IQ, OQ, and PQ execution.
• Experience in medical device validation.
• Ability to clearly explain validation concepts (IQ/OQ/PQ).
• Ability to work independently with minimal ramp-up.

• Prior experience or similar environments.
• Experience as a repeat contractor in regulated environments.
• Exposure to software validation within equipment systems.

• Strong communication skills.
• Ability to collaborate across teams.
• Comfortable in fast-paced, high-priority environments.
• Not siloed; team-oriented approach.

• Bachelor's degree in engineering required.
• 5-7 years of experience required.