process engineer San Diego, CA
Job description
The Opportunity
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 Role
As we continue to grow as QuidelOrtho, we are seeking a Manufacturing Process Engineer to work at our San Diego office. The Manufacturing Process Engineer will assist in the design, implementation, and support of continuous improvements of high-capacity processes to produce multiple device platforms within Quidel. 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 Quidel.
The Responsibilities
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 contractors to design, build, and qualify right-sized manufacturing equipment. Generates protocols and support documentation for Process Qualification (PQ) validations. 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.
The Individual
B.S. in Mechanical or Manufacturing Engineering or equivalent experience required.
Minimum 3-5 years experience in process/equipment development, with 2+ years’ experience in a regulated Medical Drug/Device manufacturing environment.
Must be able to resolve moderately complex technical problems and progressively gain the skills to solve complex problems with supervision.
Must have a thorough understanding of machine function, electro/mechanical operations and controls, and how both fit within overall system integration.
Knowledge and ability to use computer applications that include Solid Works, MS Word, Excel, and Project. May include Lab View and statistical analysis software.
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.
Basic knowledge of regulations governing medical device design and manufacturing.
Experience with designing and executing technical experiments, verification, and validation protocols.
The Key Working Relationships
Research & Development, Manufacturing, Quality Assurance/Regulatory, Project Management, Marketing/Product Management
The Work Environment
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.
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 $78,600 to $145,000. 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.
Equal Employment 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 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 [email protected]
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