Senior Product Development Engineer

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

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

At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. 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.

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

The Key Working Relationships

Internal Partners:

• Engineering Team


• Program Managers


• Assay Development Scientists


• Manufacturing Team


• Design Quality


• Regulatory Affairs

External Partners:

• Contract design and manufacturers

How We Work

At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together - Collaborate intentionally, grow as a team


• Make It Happen - Focus on priorities, embrace continuous improvement


• Commit to Service - Cultivate a service mindset


• Embrace Inclusion - Be open and authentic, welcome diverse perspectives

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

Physical Demands

No strenuous physical activity required. Occasional light lifting of materials may be needed. Substantial time will be spent in virtual or in-person meetings, engaging with customers, and working on scientific content and documentation.

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, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $130,000 to $145,000 and is bonus eligible. 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 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 [e-mail].

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