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Manufacturing Engineer

Compunnel, Inc.

Irvine, CA

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JOB DETAILS
SALARY
$62–$62 Per Hour
JOB TYPE
Temporary, Full-time
SKILLS
Analysis Skills, Blueprints, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Communication Skills, Detail Oriented, Engineering Drawing, Engineering Software, Equipment Validation, Maintain Compliance, Manufacturing, Manufacturing Engineering, Medical Equipment, Onboarding, Performance Reviews, Problem Solving Skills, Process Validation, Product Data Sheet, Quality Assurance, Regulatory Compliance, Reporting Skills, Requirements Validation/Verification, Schematics, Software Validation, System Validation, Team Player, Timing Verification
LOCATION
Irvine, CA
POSTED
2 days ago
Job Summary Th e Manufacturing Engineer applies engineering theory and principles to industrial layout and manufacturing production challenges. This role is focused on validating equipment through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The position is critical to accelerating equipment validation timelines and requires a candidate who can contribute immediately with minimal onboarding. Key Responsibilities E xecute IQ, OQ, and PQ validation of complex systems and equipment Study time, motion, methods, and speed in maintenance and production operations to establish standard rates and improve efficiency Interpret engineering drawings, schematics, and formulas to determine quality and reliability standards Review worker logs, product sheets, and specifications to verify adherence to QA standards Plan work assignments based on performance, machine capacity, schedules, and potential delays Prepare charts, graphs, and diagrams to illustrate workflow, routing, layouts, and utilization Observe equipment operation to ensure compliance with QA standards Conduct time and fatigue studies using timing devices Evaluate data and prepare reports to validate or identify deviations from standards Required Skills Hands-on expertise with IQ, OQ, and PQ execution Experience in medical device validation Ability to clearly explain validation concepts (IQ/OQ/PQ) Strong problem-solving, analytical, and communication skills Ability to create engineering drawings, sketches, and computations Proficiency in reading and interpreting blueprints, schematics, and technical reports Experience with CAD or related engineering software Team-oriented, detail-focused, and adaptable in fast-paced environments Must-Have Requirements Dir ect experience executing IQ, OQ, and PQ validations Background in medical device validation Ability to work independently with minimal ramp-up Nice-to-Have Prio r experience with Client or similar regulated environments Repeat contractor experience in regulated industries Exposure to software validation within equipmen t systems Soft Skills S trong communication and collaboration skills Comfortable in high-priority, fast-paced environments Team-oriented approach; not siloed Ability to quickly understand project scope and deliver results Top Candidate Indicators Ca n hit the ground running with minimal guidance Quickly grasps project scope and requirements Demonstrates deep validation experience and independen ce Education & Experience Bachelor’s degree in Engineering required 5–7 years of experience in manufacturing engineering and equipment validation Education: Bachelors Degree

About the Company

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Compunnel, Inc.