QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Senior Equipment/Manufacturing Engineer is responsible for the implementation of equipment systems to manufacture consumable devices for all Quidel products including Sofia, QuickVue, Triage, Savanna and other new products. This position reports to the Advanced Operations Group. This person will develop equipment specifications, oversee equipment designs, assembly, debug, and support equipment installation and system validation. This role will oversee and manage equipment builders and contractors to design and build standard and custom manufacturing equipment per Quidel specifications for pilot, low-volume and high-volume production lines. This is a cross-functional role that will interact daily with other departments such as Manufacturing management, Quality, Finance, and R&D and provide technical support where necessary to optimize equipment yields. This role must demonstrate a heightened sense of urgency in resolving matters related to manufacturing and contribute positively in a fast-paced Operations environment. This position operates independently and requires the employee to think critically about problems and situations to recommend solutions that are in the best interest of Quidel. This position will be located onsite in San Diego, CA.

• Generates equipment specifications, identifies equipment suppliers and supports equipment build activities including design reviews, debug, FAT, SAT, installation, validation and production start-up. Develops training protocols and conducts operator and maintenance training on new equipment.

• Assist with generating protocols and support documentation for Installation & Operation validations, special project plans, operating procedures and maintenance protocols for production equipment.

• Develop new equipment strategies and provide cost justifications to support procurement of capital equipment. Lead initiatives to achieve manufacturing cost objectives including optimization strategies for production yield, material and labor usage, and adherence to factory metrics.

• Works with R&D and Engineering peers on new processes and quality support equipment. Performs analysis and testing as requested to support raw material and part compatibility.

• Carries out duties in compliance with established business policies.

• Leads and is personally accountable for high profile project timelines and milestones.

• Provides technical updates to management and is accountable for costs and project timelines.

Required Skills:

• B.S. in Mechanical or Manufacturing Engineering,or equivalent experience,required

• 8+ years of experience in Medical Device high-volume Manufacturing required.

• Must be able to resolve complex technical problems independently with minimum supervision.

• Must be organized, detail oriented, and have strong verbal and written communication skills.

• Ability to work with minimal supervision.

• Must have a thorough understanding of machine function, electro-mechanical operations and controls.

• Strong analytical and problem-solving skills.

• Must be proficient at troubleshooting and take a creative and constructive approach to problem solving.

• Take a proactive approach to the performance of job assignments with minimal input from supervision, requires decision making to a level that can affect overall manufacturing efficiency.

• Excellent organizational and prioritization skills, ability to manage multiple tasks/projects simultaneously and be able to react/change directions quickly and efficiently.

• Experienced at conducting and supporting equipment validations.

• Ability to work within cross functional teams.

• Ability to participate in planning and managing projects.

• Basic knowledge of regulations governing medical device assembly and design.

• Knowledge and ability to use computer applications that include SolidWorks and MSOffice including MSProject.

• Knowledge of related quality systems, regulations and processes.

• Knowledge of the budgeting process, planning, and building realistic timelines.

Internal Partners:

Product Development/R&D, Manufacturing, Quality Assurance, Technical Support, Marketing

External Partners:

Suppliers

The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines and support of manufacturing goals. The position requires ability to flexibly spend time on the desk, analyzing data, in meetings as well as hand-on product testing as needed. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.

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 $92,900 to $170,000 and is bonus eligible or eligible for incentive compensation. 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.

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 their 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

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