The Role

At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Process Engineer. This position provides direction and support to the manufacturing area utilizing structured problem-solving skills and acquired scientific/engineering knowledge to resolve manufacturing issues that impact product quality and delivery. Key activities include, but are not limited to, monitoring of current manufacturing processes, reduction of variation, control/mitigation of process drift, leading / supporting troubleshooting investigations, implementing manufacturing process improvements, assessing feasibility of new manufacturing technology, ensuring manufacturing process robustness, revising/creating new documentation for Manufacturing (manufacturing instructions, routings, bills of material, SOPs, etc.), validation of new or improved manufacturing processes and equipment and integrating new products from R&D into manufacturing.

This position will be onsite in Carlsbad, CA.

The Responsibilities

• Provide technical and strategic leadership in the design, development, and optimization of manufacturing processes for diagnostic reagents and related products, ensuring scalability, robustness, and long-term operational excellence.
• Lead cross-functional collaboration with R&D, Quality, Operations, Regulatory, and Supply Chain to define, refine, and standardize process specifications that align with business objectives and compliance requirements.
• Drive continuous process improvement initiatives, leading efforts to characterize, optimize, validate, and implement Engineering Change Orders (ECOs) to enhance efficiency, reduce variability, and strengthen process capability.
• Own and lead technical investigations related to NCMRs, CAPAs, deviations, and failure analyses within the Chemistry Manufacturing area, ensuring timely root cause identification, risk mitigation, and sustainable corrective actions.
• Lead/support internal and external manufacturing audits, partnering with cross-functional stakeholders to assess process performance, identify gaps, and implement effective corrective and preventive actions.
• Serve as the process engineering lead in R&D-to-Manufacturing transfer activities, guiding scale-up strategies, assessing production readiness, and ensuring seamless integration into commercial manufacturing.
• Champion adherence to the Quality Management System, modeling compliance excellence and reinforcing alignment with business policies, regulatory standards, and industry best practices.
• Drive Lean and Six Sigma deployment, mentoring team members and leading structured improvement projects to elevate product quality, increase throughput, and strengthen operational efficiency.
• Act as a technical mentor and thought leader within the Process Engineering function, elevating team capability and fostering a culture of accountability, innovation, and continuous improvement.
• Performs other duties & projects as assigned

The Individual

Required:

• Bachelor's degree in Chemistry, Biochemistry, Engineering or related field.
• Minimum of 8-10 years experience in process engineering, with a background in the fields of diagnostics, biochemistry, or immunochemistry.
• Experience with regulatory compliance standards (e.g., FDA, ISO).
• Good problem-solving skills, including root cause analysis and data driven decision making.
• Excellent teamwork and communication skills.
• Knowledge of statistical tools and data analysis software such as JMP, Excel and Minitab.
• Working knowledge of manufacturing tools and processes (i.e. BOM, Routings, SPC Charts)
• This position is not currently eligible for visa sponsorship.

Preferred:

• Experience in lateral flow technology preferred.
• Experience with antibody purification processes.
• Experience with analytical method development (ELISA, HPLC, Flow Cytometry).
• Key Working Relationships
• Deals with all technical functions (Chemistry, Manufacturing, Engineering, Quality, R&D, and Regulatory) on a continual basis presenting technical expertise and support as needed. Works with Chemistry Manufacturing to address manufacturing problems, solutions and improvements in the manufacturing areas. Participates in cross-functional teams and may lead / support interdepartmental project team/s.
• The Work Environment
• The work environment characteristics are representative of both an office and laboratory environment and may include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

The Physical Demands

Position requires ability to lift up to 20 lbs. on occasion. Up to 75% of time at lab bench or desk, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

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 $102,360.25 - $130,000 USD Annual annually. 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.

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