Senior Diagnostics Product Engineer — Flexible Hours

QuidelOrtho; San Diego (CA); On-site; USD 130,000 - 145,000; Full time

Job summary

QuidelOrtho in San Diego (Summers Ridge) is seeking a Senior Product Development Engineer to lead new product development and instrument integration for point-of-care diagnostics. You will design, validate, and transfer consumables and assays into manufacturing, collaborating across R&D, manufacturing, and quality teams.

The role requires a Bachelor's with 7+ years or Master's with 5+ years in a relevant engineering discipline, expertise in diagnostic tests, and ability to make strategic

Qualifications

• Bachelor's degree with 7+ years of experience; master's with 5+ years 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.
• Willingness and ability to travel up to 10%.

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.

Education

Bachelor's degree + 7+ years

Master's degree + 5+ years

Job description

QuidelOrtho in San Diego (Summers Ridge) is seeking a Senior Product Development Engineer to lead new product development and instrument integration for point-of-care diagnostics. You will design, validate, and transfer consumables and assays into manufacturing, collaborating across R&D, manufacturing, and quality teams.

The role requires a Bachelor's with 7+ years or Master's with 5+ years in a relevant engineering discipline, expertise in diagnostic tests, and ability to make strategic