Senior Equipment Engineer

The Role

The Senior Equipment Engineer provides engineering expertise in all areas of manufacturing equipment selection and integration, process development and improvement, and project support to ensure the production of world class products. This role is a true self-starter and provides engineering leadership in high-volume manufacturing.

This is an onsite role in Carlsbad, CA.

The Responsibilities

• Selects, manages, integrates, installs, diagnoses, and operates various manufacturing equipment, robotics, programmable logic controls, electropneumatics, measurement tools, and other equipment for manual and automated assembly manufacturing lines.
• Works closely with vendors and can lead large-sized capital equipment projects. This can include regular design reviews, milestone setting, and travel to vendors.
• Writes, executes, and reviews documentation for production operations including manufacturing and equipment instructions, validation protocols, design control, pFMEA, and control plans for new, modified, and relocated equipment.
• Develops manufacturing control plans and metrics that verify machine outputs are compliant with QSR standards.
• Creates, maintains, and improves manufacturing documentation including SOPs, work instructions, BOMs, and routings. Works closely with other staff to deploy and train on new procedures and instructions.
• Analyzes measurement, machine, process, and product data with basic statistical methods.
• Identifies critical projects and initiatives to improve efficiency, capacity, and redundancy and reduce waste with little supervision. Monitors and improves key performance metrics such as yield, scrap, OEE, and throughput.
• Leads or works closely with cross-functional teams involving R&D, Quality, Operations, Supply Chain, and external partners, providing engineering guidance for projects and problem-solving activities.
• Leads or supports audits, CAPA investigations, NCR resolution, and change control (ECOs) activities.
• Organizes and manages team meetings, generates agendas, and writes meeting minutes.
• Develops and maintains budgets for multi-tasked projects and conducts the financial analysis necessary to justify procurement of new capital equipment and supports the development of contractual agreements that incorporate supplier accountability for cost, schedule, and quality.
• Interprets and generates mechanical part designs via CAD models, piece part drawings, and assembly drawings.
• Fabricates piece parts or modifies equipment as needed, using common fabrication methods such as conventional milling, turning, laser cutting, welding, and soldering.
• Able to complete basic component electrical wirings, including the ability to interpret electrical drawings.
• Carries out duties in compliance with established policies.
• Trains other staff in all areas of knowledge and expertise and acts as a key organization resource.
• Perform other work-related duties as assigned

The Individual

Required Skills:

• BS degree in an engineering discipline, preferably Mechanical, Manufacturing or Industrial Engineering or equivalent work experience.
• 5 years of experience in a pharmaceutical or medical device environment in a high-volume manufacturing environment.
• Subject matter expert on more than three pieces of equipment and/or manufacturing processes.
• Understands cGMP and lean manufacturing principles.
• Expert problem solving skills
• Excellent verbal and written communication skills
• This position is not currently eligible for visa sponsorship.

Preferred Skills:

• Highly experienced in electrical-mechanical theory and application, manufacturing and fabrication process, automated assembly, 2D & 3D CAD, programmable logic controls, measurement methods, hardware design, pneumatics, basic finance theory, and basic quality tools preferred.

The Key Working Relationships

Internal: Quality, Maintenance, Research and Development, Facilities, Planning, Finance, Engineering Technicians

External: Outside service providers

The Work Environment

Work environment is representative of manufacturing, laboratory, and office settings. Some travel is required to other production facilities and vendors.

The Physical Demands

Physical demands require the individual to lift loads up to 50lbs, work within restricted areas confined by equipment, and work within a low humidity environment with potential exposure to biological, toxic, and corrosive reagents (50% of time). The individual is also required to work within the confinements of a cubical style office, and also within a laboratory setting (50%). Must be willing to work flexible hours, including after-hour on-call support of manufacturing equipment and lines.