Senior Equipment Engineer

QuidelOrtho•Carlsbad, CA

1d•$105,000 - $115,000•Onsite

About The Position

The Senior Equipment Engineer provides engineering expertise in manufacturing equipment selection and integration, process development and improvement, and project support to help ensure the production of world-class products. The role provides engineering leadership in high-volume manufacturing and requires a self-starting approach. It is an onsite position in Carlsbad, California. The engineer works with manufacturing equipment and production processes, supports capital equipment projects, prepares and maintains manufacturing documentation, and collaborates with cross-functional teams and external partners. The role also includes equipment design and modification, data analysis, staff training, and support for quality and compliance activities. Some travel to production facilities and vendors is required. The position requires flexible hours, including after-hours on-call support for manufacturing equipment and lines.

Requirements

Bachelor’s degree in an engineering discipline, preferably Mechanical, Manufacturing, or Industrial Engineering, or equivalent work experience.
At least 5 years of experience in a pharmaceutical or medical device environment in high-volume manufacturing.
Subject matter expertise on more than three pieces of equipment and/or manufacturing processes.
Understanding of cGMP and lean manufacturing principles.
Expert problem-solving skills.
Excellent verbal and written communication skills.
Ability to lift loads up to 50 pounds, work in restricted areas confined by equipment, and work in a low-humidity environment with potential exposure to biological, toxic, and corrosive reagents.
Ability to work in a cubicle-style office and laboratory setting.
Willingness to work flexible hours, including after-hours on-call support of manufacturing equipment and lines.
This position is not currently eligible for visa sponsorship.

Nice To Haves

Experience with electrical-mechanical theory and application, manufacturing and fabrication processes, automated assembly, 2D and 3D CAD, programmable logic controls, measurement methods, hardware design, pneumatics, basic finance theory, and basic quality tools.

Responsibilities

Select, manage, integrate, install, diagnose, and operate manufacturing equipment, robotics, programmable logic controls, electropneumatics, measurement tools, and other equipment for manual and automated assembly lines.
Work with vendors and lead large capital equipment projects, including design reviews, milestone setting, and vendor travel.
Write, execute, and review production documentation, including manufacturing and equipment instructions, validation protocols, design control documents, pFMEAs, and control plans for new, modified, and relocated equipment.
Develop manufacturing control plans and metrics to verify machine outputs comply with QSR standards.
Create, maintain, and improve manufacturing documentation, including SOPs, work instructions, BOMs, and routings; collaborate with staff to deploy and train on new procedures and instructions.
Analyze measurement, machine, process, and product data using basic statistical methods.
Identify and lead projects to improve efficiency, capacity, and redundancy and reduce waste; monitor and improve yield, scrap, OEE, and throughput.
Lead or collaborate with cross-functional teams involving R&D, Quality, Operations, Supply Chain, and external partners, providing engineering guidance for projects and problem-solving activities.
Lead or support audits, CAPA investigations, NCR resolution, and change-control activities, including ECOs.
Organize and manage team meetings, prepare agendas, and write meeting minutes.
Develop and maintain budgets for multiple projects; conduct financial analyses to justify capital equipment procurement and support contractual agreements that establish supplier accountability for cost, schedule, and quality.
Interpret and generate mechanical part designs using CAD models, piece-part drawings, and assembly drawings.
Fabricate piece parts or modify equipment using methods such as conventional milling, turning, laser cutting, welding, and soldering.
Complete basic component electrical wiring and interpret electrical drawings.
Carry out duties in compliance with established policies.
Train other staff in areas of expertise and serve as a key organizational resource.
Perform other work-related duties as assigned.