Manufacturing Engineering Technician III

Marquee Staffing; Irvine (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Marquee Staffing seeks a Manufacturing Engineering Technician in Irvine, CA to support and qualify manufacturing processes, materials, tooling, and fixtures for productivity and quality improvements. The role requires hands-on problem solving, cross-functional communication, and Agile Scrum collaboration with R&D and QA.

Ideal candidates have an Associate Degree in engineering and 3–5 years in a medical device setting, with knowledge of QSRs/GMPs, reading drawings and using hand tools.

Qualifications

• Associate degree in engineering required with relevant work experience.
• 3–5 years in a medical device environment preferred.
• Familiar with QSRs/GMPs and able to read mechanical drawings/electrical schematics.

Responsibilities

• Build, troubleshoot, and qualify manufacturing processes, materials, tooling, and fixtures.
• Develop and release production support documentation (IQ/OQ/PQ protocols and reports).
• Lead DVT testing and process validation activities.
• Perform root cause analysis and implement corrective actions.
• Collaborate with R&D, Operations, and QA in a fast-paced start-up environment.

Skills

Technical problem solving

Analytical thinking

Hands-on

Multi-tasking

Cross-functional communication

Agile/Scrum familiarity

Education

Associate Degree in Mechanical/Manufacturing/Electrical engineering

Job description

Manufacturing Engineering Technician (direct hire) Irvine, CA

Responsible to build, troubleshoot and qualify manufacturing processes, materials, tooling, and fixtures to meet manufacturing needs while enhancing productivity and product quality. Critical attributes and skills include technical problem solving, initiative, ability to analyze problems, use a hands-on practical approach, multi-tasking, and communicating between groups within the company. Works with a cross-functional team utilizing the Agile Scrum project planning process.

Essential Duties and Responsibilities

• Works closely with R&D to support new product development by building, troubleshooting, testing and implementing new processes through process validation.
• Works closely with Operations and QA to develop and release production support documentation, including IQ/OQ/PQ protocols and reports.
• Responsible for equipment troubleshooting and basic repair.
• Takes a lead role in executing DVT testing.
• Responsible to manage tasks and communication to management as needed to ensure status updates on projects.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations including compliance to EN ISO 13485, Medical Device Quality Standards.
• Perform root cause analysis to resolve issues.
• Execute multiple project activities concurrently to achieve timeline requirements; use resources effectively and efficiently while adjusting to changing priorities in a start-up environment.
• Excellent interpersonal, verbal and written communication skills.
• Meticulous attention to detail and meeting deadlines.

Required Education and Experience

Associate Degree in Mechanical, Manufacturing, Electrical engineering discipline or combination of education and applicable work experience. 3-5 years of experience in a medical device environment. Ability to apply principles outlined in Quality System Regulations (QSRs/GMPs). Ability to use basic hand tools such as drills, micrometers, calipers, etc. Ability to operate electrical and mechanical equipment and interpret results. Must be able to read and interpret mechanical drawings and electrical schematics. Proficient with Microsoft Office and on-line applications.

Preferred Experience and Qualifications

Experience in Medical Device, or Consumer Electronics preferred. Experience in FDA/GMP/ISO environment preferred. Works in a Lab, Clean Room, and Warehouse environment, within a well-lighted work area with good ventilation and normal noise levels from lab, shop equipment, and clean room.

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