Senior Equipment Engineer

Ortho Clinical Diagnostics; Carlsbad (CA); On-site; USD 105,000 - 115,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan

Paid time off

Paid Holidays

Job summary

QuidelOrtho is seeking a Senior Equipment Engineer in Carlsbad, CA to lead equipment selection, installation, and optimization for high-volume manufacturing. You will work with R&D, Quality, Operations, and vendors to ensure compliant, efficient production of world-class products.

The role requires a BS in engineering, 5 years of pharma/medical device experience, and strong problem-solving and communication skills. Onsite work with potential travel to facilities and vendors is expected.

Qualifications

• 5 years of experience in a pharmaceutical or medical device environment in high-volume manufacturing.
• 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.

Responsibilities

• Selects, integrates, installs, diagnoses, and operates manufacturing equipment and related systems.
• Leads capital equipment projects with vendors and cross-functional teams.
• Develops and maintains manufacturing control plans, validation protocols, and change control activities.
• Monitors KPIs (yield, scrap, OEE, throughput) and drives improvement.
• Trains staff on new procedures and instructions.

Skills

Lean manufacturing

cGMP

Cross-functional collaboration

Education

BS in Mechanical/Manufacturing/Industrial Engineering

Tools

CAD (2D & 3D)

PLC controls

Fabrication methods

Job description

QuidelOrtho develops and manufactures advanced diagnostic solutions that make a meaningful difference in the lives of millions of people every day. United by a shared purpose, our passionate, driven employees come together to transform data into understanding and action for healthcare professionals, patients and communities around the world. Together, we’re creating a lasting impact where it is needed most and advancing the power of diagnostics for a healthier future for all.The RoleThe 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 ResponsibilitiesSelects, 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 assignedThe IndividualRequired 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 skillsExcellent verbal and written communication skillsThis 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 RelationshipsInternal:QualityMaintenanceResearch and DevelopmentFacilitiesPlanningFinanceEngineering TechniciansExternal:Outside service providersThe Work EnvironmentWork environment is representative of manufacturing, laboratory, and office settings. Some travel is required to other production facilities and vendors.The Physical DemandsPhysical 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.Salary TransparencyThe salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $105,000 - 115,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.Equal OpportunityQuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [e-mail] .#LI-HF1