Product Development Engineer-PCR Consumable Development @ Quidel - San Diego, CA

Job Overview

2 months ago

Product Development Engineer-PCR Consumable Development

Quidel - San Diego, CA

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!

Under minimal supervision, the Product Development Engineer is responsible for platform consumables development and functions in the capacity of an individual contributor advancing designs from conception through commercialization. This is a multidisciplinary role requiring technical expertise in device design, assay optimization, consumable workflow, plastics, fluidics, and instrument integration. This position has overall responsibility for delivering the technical solutions as dictated by defined product requirements.

ESSENTIAL FUNCTIONS:

    • Actively participates on design teams, understands R&D goals and timelines, and provides leadership to ensure product launch success.
    • Assists in design, development and transfer of new products into manufacturing.
    • Actively communicates project status, challenges, concerns and resource constraints to area management.
    • Writes reports, documents and validation protocols.
    • Consults on troubleshooting and aid in improvement of manufacturing processes.
    • Carriesoutdutiesincompliancewithestablishedbusinesspolicies.
    • Works with R&D Scientists to develop, automate, optimize and integrate diagnostic assays with instrumentation equipment.
    • Ensures develop ment 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 Quidel and external regulatory requirements as part of the design control process.
    • Maintains a safe working environment.
    • Leads the development of the DFMEA and PFMEA.
    • Develops raw material in process and product specifications.

EDUCATION/EXPERIENCE:

    • Bachelor’s Degree in Mechanical, Manufacturing, Electrical or Industrial Engineering or equivalent. Master’s Degree highly preferred.
    • 5+ years of related experience, preferably in a pharmaceutical or medical device environment.

KNOWLEDGE/SKILLS:

    • Mechanical Theory & Application.
    • CAD, Solidworks.
    • Fluidics and consumable product development.
    • Finite Elements Analysis, SW simulations.
    • Strong analytical and problem-solving skills.
    • Good organizational skills, and the ability to manage multiple tasks.
    • Experience in product development and experimental design.
    • Ability to work in cross functional teams.
    • Strong communication skills, written and verbal.
    • Strong knowledge of relevant analytical tools.
    • Ability to participate in planning and managing projects.
    • Working knowledge of manufacturing tools and processes (i.e.BOM, Routings, SPC Charts, FMEA).
    • Knowledge of related quality systems regulations and processes.
    • Appropriate computer skills(e-mail, word processing, statistical, spreadsheet and graphing software).
    • Independently supports the Operation’s manufacturing vision on the R&D project teams.
    • Resolves complex technical problems through teamwork, communication and application of technical expertise.
    • Provides engineering expertise in the development and implementation of functional strategies to support corporate goals and objectives.
    • Responsibilities include integrating engineering theory and practice within the areas of new product development, manufacturing and marketing support.

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.

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