Title:
Sr Manufacturing Engineer
Location:
Irvine, CA
Pay:$50.00-$59.00/hour
Schedule:
Standard Office Hours
Duration:
9-Month Initial Contract
The Manufacturing Engineer applies engineering principles to optimize industrial layout and manufacturing production processes. This role focuses on validating equipment through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
This position is critical to accelerating validation timelines and requires a candidate who can contribute immediately with minimal onboarding.
Key Responsibilities
- Lead and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) activities for complex systems and equipment
- Analyze time, motion, methods, and production speeds to establish standard rates and improve operational efficiency
- Interpret engineering drawings, schematics, and technical data to determine quality and reliability standards
- Review worker logs, processing sheets, and specifications to ensure compliance with quality assurance requirements
- Support planning of work assignments based on performance, equipment capacity, production schedules, and potential delays
- Develop charts, graphs, and diagrams to illustrate workflows, layouts, material handling, and equipment utilization
- Observe equipment operation to ensure adherence to quality and maintenance standards
- Conduct time studies to evaluate task duration and fatigue factors
- Analyze data and prepare reports to validate processes or identify deviations from established standards
Required Skills
- Strong analytical, problem-solving, and communication skills (verbal and written)
- Detail-oriented with a collaborative, team-focused mindset
- Ability to create sketches, engineering drawings, and perform standard calculations
- Proficient in interpreting blueprints, schematics, and technical documentation
- Experience with engineering software tools, including Computer-Aided Design (CAD)
Must-Have Qualifications
- Hands-on experience executing IQ, OQ, and PQ validation activities
- Background in medical device validation or regulated environments
- Ability to clearly explain validation concepts (IQ/OQ/PQ)
- Proven ability to work independently with minimal onboarding
Preferred Qualifications
- Experience in similar regulated manufacturing environments
- Previous contract experience in validation-focused roles
- Exposure to software validation within equipment systems
Soft Skills
- Strong interpersonal and communication abilities
- Effective cross-functional collaboration
- Comfortable working in fast-paced, high-priority environments
- Team-oriented mindset with a proactive approach
Education & Experience
- Bachelor’s degree in Engineering (required)
- 5–7 years of relevant experience
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