Senior Equipment Engineer

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.

As we continue to grow as QuidelOrtho, we are seeking a Senior Equipment Engineer to work at our San Diego office. The Senior Equipment Engineer will assist in the design, implementation, and support of continuous improvements of high-capacity processes to produce multiple device platforms within QuidelOrtho. This position will recommend process/equipment specifications, oversee custom process/equipment designs and fabrication, and support equipment installation and system validation. This is a cross-functional role that will interact routinely with R&D, Manufacturing, Quality, Regulatory, Marketing, and Project/Product Management to provide technical support throughout a product's commercial life cycle. This role must demonstrate a heightened sense of urgency in resolving matters related to product manufacturability and contribute positively in a fast-paced Operations environment. This position operates collaboratively within the overall Advanced Engineering team and thinks critically as problems and situations arise to recommend solutions that are in the best interest of QuidelOrtho.

This position will be located onsite in Summers Ridge, San Diego, CA.

• Participate in product design efforts to ensure that design for manufacturability is incorporated into platform consumables and that selected raw materials are compatible with proposed manufacturing processes.

• Collaborates with R&D to develop appropriate process and equipment specifications. Assures these specifications are implemented throughout life cycle of process/product.

• Works with equipment suppliers to design, build, and qualify right-sized manufacturing equipment.Generates protocols and support documentation for validations (IQ, OQ and PQ).Develops training protocols and conducts operator and maintenance training on new process equipment.

• Troubleshoots processing and equipment problems and works with other departments to identify root cause(s) and implement(s) corrective actions.

• Explores and develops new processing strategies and equipment to support continuous improvement of product line.

• Carries out duties in compliance with established quality, regulatory, and business policies.

• Performs other work related duties as assigned.

• B.S. in Mechanical, Manufacturing Engineering or similar discipline is required.

• Minimum 6 years of experience in process/equipment development, with 3 years experience in a regulated high-volume Medical Device manufacturing environment or similar environment is required.

• Must be able to resolve complex technical problems independently with minimum supervision. Must be proficient at troubleshooting and take a creative and constructive approach to problem solving.

• Must have a thorough understanding of machine function, electro/mechanical operations and controls, and how both fit within overall system integration.

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

• Knowledge and ability to use computer applications that include Cognex Insight, Solid Works, MS Word, Excel, and Project. May include Lab View and statistical analysis software (JMP).

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

• Take a proactive approach to the performance of job assignments with input from management and peers. Requires decision making to a level that can affect overall manufacturing efficiency.

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

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

• Experience with designing and executing technical experiments, verification, and validation protocols.

Internal: Research & Development, Manufacturing, Quality Assurance/Regulatory, Supply Chain, Project Management, Finance, Marketing/Product Management

External: External contractors and vendors.

The work environment characteristics are representative of an office, laboratory, and manufacturing environment. Core work hours with occasional flexibility to meet project deadlines and support of manufacturing goals. Position requires ability to flexibly spend time sitting and standing working at a desk, collaborating in meetings, and hands-on product testing in a laboratory or manufacturing environment. Specific vision abilities require close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted. This position may require travel up to 20% of the time to offices, suppliers (domestic and international).

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 $92,000 to $156,000. 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 recruiting@quidelortho.com.