San Diego, CA /
Research & Development – Research & Development /
Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. We are a leading manufacturer of point of care diagnostic solutions. Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.
We are excited to announce that Quidel Corporation is now becoming QuidelOrtho! This transaction will bring together two world-class teams and complementary product portfolios to serve patients around the world. During this transition period, we encourage you to continue visiting our career site and also check out more career opportunities at Careers at Ortho Clinical Diagnostics | Ortho Clinical Diagnostics jobs Join our journey as we become one global diagnostics leader!
Quidel is looking for a Bioengineer to join our team in the Mira Mesa area of San Diego. The Bioengineer provides technical expertise to the design and development of new and novel medical device product(s). Designs and implements new methodologies, materials, machines, processes, or products. Develops new concepts from initial design to market release. Conducts feasibility, development, verification and validation studies of the design to determine the product’s ability to function as intended. Maintains detailed documentation throughout all phases of research and development. Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
- Construct and execute controlled experiments as part of the development process for a cartridge-based immunoassay based on microfluidics, bringing together material science, microfluidics and thermodynamics considerations
- Work on teams to develop and transfer new processes/products to production.
Education and Experience:
- Bachelor’s degree in biochemistry, chemistry, physics, bioengineering, related field, or equivalent and 3 years of related experience or,
- Master’s degree in biochemistry, chemistry, physics, bioengineering, related field, or equivalent and 1 year of experience or,
- PhD or equivalent with related research work in area related to assay development or system or device engineering
- Successful cartridge-based immunoassay development experience required
- Experience implementing solutions in a regulated environment preferred
- Engineering acumen for the design, development, validation and deployment of novel POC assays
- Understanding of the overall cartridge design process in terms of its manufacturability and balancing trade-offs between cost and overall assay performance requirements.
- Able to take input and model products from concept to finished design in CAD
- Contributes to the creation or modification of manufacturing processes to make product, from start to finish, with Design for Manufacture (DFM) top of mind
- Experience with development of diagnostic products using biomarkers in the Point of Care setting
- Conceptual, analytical, and problem-solving ability
- Experience with Design for Manufacturability and Assembly (DFMA)
- Excellent computer skills - CAD, word processing, and spreadsheets.
- Good communication skills, both verbal and written and the ability to effectively interface within a cross-functional team environment
- Understanding of modern manufacturing principles and techniques
- Knowledge of CGMP requirements and preferably FDA and ISO 9000 requirements
- Working knowledge of medical device regulatory requirements and standards and the ability to apply these during the development process
- Demonstrated knowledge of the basic elements of evaluation and interface of chemistry, materials, fluidics and molded/machined part design
- Influencing skills and the ability to foster strong interpersonal relationships between groups
- Demonstrated understanding of the budgeting process, planning, and building realistic timelines
- Contributes to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA, and other regulatory agencies
- Understands the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
Before you apply, please make sure you share Quidel’ s values. We pride ourselves on keeping these values in mind every day as we execute on goals and plan for the future. We are seeking employees who share the same mindset and commitment to be customer driven, focused on execution, and new product oriented. We succeed by being determined, optimistic team players.
Quidel is proud to be an Affirmative Action/Equal Opportunity Employer (Minorities/Women/Disabled/Veterans). We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.