Product Development Engineer-PCR Consumable Development

Company: Ortho Clinical Diagnostics
Location: San Diego
Posted on: March 20, 2023

Job Description:

The Opportunity

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

As we continue to grow as QuidelOrtho, we are seeking a Product Development Engineer-PCR Consumable Development who will be 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. This position is onsite.

The Responsibilities

• 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.
• Carries out duties in compliance with established business policies.
• Works with R&D Scientists to develop, automate, optimize and integrate diagnostic assays with instrumentation equipment.
• 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 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. The Individual
  
  Required Skills:
  • 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.
  • 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. The Key Working Relationships
    • Internal partners: Ability to work with personnel at all levels of the organization.
    • External partners: All external vendors. The Work Environment
      • This position operates in a typical office environment.
        
        Salary Transparency
        
        The salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, its is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. A salary range for this position is $78,600 to $145,000. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
        
        Equal Employment Opportunity
        
        QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at orthorecruiting@orthoclinicaldiagnostics.com
        
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Keywords: Ortho Clinical Diagnostics, San Diego , Product Development Engineer-PCR Consumable Development, Engineering , San Diego, California