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About the Role
As a Senior Product Development Engineer supporting Point-of-Care at QuidelOrtho, you will be instrumental in new product development, on-market support, instrument and consumable product design, assay integration, scale-up, technology transfer, and validation. This role involves active participation in design teams, understanding R&D goals, and providing leadership updates to ensure successful product launches. You will integrate engineering theory and practice across new product development, manufacturing, and marketing support.
Responsibilities
- Designs, develops, and transfers new products into manufacturing.
- Communicates project status, challenges, concerns, and resource constraints to management.
- Writes reports, documents, and validation protocols, maintaining detailed notebook records.
- Consults on troubleshooting and aids in the improvement of manufacturing processes.
- Works with R&D Scientists to develop, automate, optimize, and integrate diagnostic assays with instrumentation.
- Provides guidance to R&D to prevent the implementation of designs that do not meet manufacturing standards.
- Ensures development activities result in manufacturing processes that are robust, technically feasible, scalable, cost-effective, and aligned with the Operations organization's vision.
- Supports the introduction of new core competencies and strives for an optimized and efficient manufacturing organization.
- Participates in design, process development, validation, documentation creation/implementation, and personnel training.
- Maintains project documentation in accordance with regulatory requirements as part of the design control process.
- Develops raw material, in-process, and product specifications.
- Performs other work-related duties as assigned.
Requirements
- Bachelor's degree with 7+ years of experience or Master's degree with 5+ years of experience in a relevant engineering discipline.
- Experience developing consumable diagnostic tests.
- Ability to make strategic decisions on technical issues, weighing regulatory, technical, and business risks.
- Recognized subject matter expert in one or more areas of product design.
- Demonstrated experience in making significant process improvements and/or implementing new processes to enhance productivity and efficiency.
- This position is not currently eligible for visa sponsorship.
- Ability to travel up to 10%.
Skills
- Product design
- Process improvement
- Communication skills
- Analytical skills
- Teamwork skills
Location
- San Diego (Summers Ridge)
Work Type
- Onsite
- Full-time
Experience Level
- Senior
Education Level
- Bachelor's degree
- Master's degree
Salary/Compensations
- $130,000 to $145,000
- bonus eligible
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401(k) plan
- Employee assistance program
- Employee Stock Purchase Plan
- Paid time off (including sick time)
- Paid Holidays
About the Company
- 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.
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 recruiting@quidelortho.com.