Senior Equipment Engineer

QuidelOrtho Corporation; Carlsbad (CA); On-site; USD 105,000 - 115,000; Full time

Job summary

QuidelOrtho in Carlsbad, CA, seeks a Senior Equipment Engineer to provide leadership in equipment selection, integration, process development, and project support for high-volume manufacturing. You will collaborate across R&D, Quality, Operations, and outside partners, write validation protocols and control plans, improve yield and OEE, and mentor staff while managing multi-task projects and budgets.

This onsite role offers a comprehensive benefits package and requires a mechanical/

Qualifications

• BS degree in engineering; mechanical/manufacturing/industrial preferred
• 5 years of pharma or medical device high-volume manufacturing experience
• Subject matter expert on ≥3 equipment or processes

Responsibilities

• Selects and integrates manufacturing equipment and PLCs for high-volume lines.
• Leads large-capital equipment projects with vendors; design reviews and milestone setting.
• Writes, reviews documentation for production operations including validation protocols, design control and control plans.
• Develops control plans and metrics ensuring machine outputs meet QSR standards.
• Creates and maintains SOPs, work instructions, BOMs and routings; trains staff on new procedures.

Skills

Engineering degree

5+ years pharma/medical device mgmt

cGMP & Lean

Problem solving

Verbal & written communication

Visa sponsor not available

Education

Engineering degree

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 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.

Salary Transparency

The 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 Opportunity

QuidelOrtho 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].