Staff Product Development Engineer

QuidelOrtho•San Diego, CA

2d•Onsite

About The Position

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 At QuidelOrtho , we’re advancing the power of diagnostics for a healthier future for all . Join our mission as our next Staff Product Development Engineer to support R&D. The Staff Product Development Engineer responsibilities will include new product development, on market support, consumable product design, assay integration into consumables, scale up, technology transfer and validation activities. This position actively participates in design teams, understands R&D goals and timelines, and provides updates to leadership to ensure product launch success. The Staff Product Development Engineer also integrates engineering theory and practice within the areas of new product development, manufacturing and marketing support. This position will be onsite full-time in San Diego, CA (Sorrento Valley).

Requirements

Bachelor's degree with 7+ years of experience, Master's degree with 5+ years of experience in relevant engineering discipline
Experience developing consumable diagnostic tests.
Ability to make strategic decisions on technical issues weighing regulatory, technical, and business risks appropriately
Recognized subject matter expert in one or more areas of product design
Demonstrated making moderate to significant process improvements and/or implementing new processes to enhance productivity and efficiency
Strong communication, analytical, and teamwork skills
Ability to travel up to 10%
This position is not currently eligible for visa sponsorship.

Nice To Haves

Experience in medical devices/diagnostics and regulated environments
Experience designing products in a regulated environment

Responsibilities

Designs, develops and transfers new products into manufacturing
Actively communicates project status, challenges, concerns and resource constraints to area management
Writes reports, documents and validation protocols and maintains detailed and organized notebook records
Consults on troubleshooting and aids in improvement of manufacturing processes
Works with R&D Scientists to develop, automate, optimize and integrate diagnostic assays with instrumentation equipment
Provides guidance to R&D as needed to prevent implementation of designs that do not meet manufacturing standards.
Ensures development activities result in manufacturing processes that are robust, technically feasible, can be scaled-up, cost effective and fit within the core competencies and vision of the Operations organization.
Supports the introduction of new core competencies, strives to ensure an optimized and efficient manufacturing organization.
Participates in design, process development and validation, creation and implementation of documentation, and training of personnel
Maintains project documentation in accordance with internal and external regulatory requirements as part of the design control process.
Develops raw material in process and product specifications
Perform other work-related duties as assigned.