Senior Product Development Engineer
QuidelOrtho
Summary
Join our mission as our next Senior Product Development Engineer supporting Point-of-Care. The Senior Product Development Engineer responsibilities will include but not limited to new product development, on market support, instrument development, 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 Senior 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 at our San Diego (Summers Ridge) location.
Job description
The 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.
The Individual
Required:
- 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
- This position is not currently eligible for visa sponsorship
- Ability to travel up to 10%
Preferred:
- Experience in medical devices/diagnostics and regulated environments
- Experience designing products in a regulated environment
- Strong communication, analytical, and teamwork skills
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
- This position is not currently eligible for visa sponsorship
- Ability to travel up to 10%
- Experience in medical devices/diagnostics and regulated environments
- Experience designing products in a regulated environment
- Strong communication, analytical, and teamwork skills
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401(k) plan
- Employee assistance program
- Employee stock purchase plan
- Paid time off
- Sick time
- Paid holidays
Company overview
QuidelOrtho Corporation is a leading American in vitro diagnostics (IVD) company formed through the merger of Quidel Corporation and Ortho Clinical Diagnostics in 2022. Headquartered in San Diego, California, the company is publicly traded on Nasdaq under the symbol QDEL and generates over $3 billion in annual revenue. With more than 120 years of collective experience, QuidelOrtho ranks among the world's largest IVD providers, offering comprehensive diagnostic solutions across point-of-care settings, clinical laboratories, and transfusion medicine. The company's extensive product portfolio includes rapid antigen tests, molecular diagnostics, immunoassays, clinical chemistry systems, and blood bank solutions. QuidelOrtho gained significant recognition during the COVID-19 pandemic for developing the first FDA emergency use authorized rapid antigen test that delivers results in 15 minutes. The company's innovative technologies span infectious disease testing, women's health, cardiac biomarkers, autoimmune disorders, and transfusion medicine, serving healthcare providers worldwide with accurate, reliable diagnostic tools that improve patient outcomes across the healthcare continuum.