Process Engineering Manager (R&D)

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 Process Engineering Manager. As manager of the process development group, you will be responsible for overseeing a team of talented engineers and scientists in the design, development, and optimization of manufacturing processes for our diagnostic products. Collaborating with cross functional teams, you will play a crucial role in ensuring the quality, scalability, and capability of our diagnostic products.

QuidelOrtho is a leader in the clinical diagnostics industry, committed to revolutionizing patient care through innovative diagnostic products. Our assay development group is at the heart of our journey, dedicated to building and commercializing innovative diagnostics tests. We're seeking an experienced and dynamic technical manager to lead our process development group which will support the development of robust diagnostic tests. This position is located in Rochester, NY.

The Responsibilities

• Lead, manage, and mentor a team of process engineers, scientists, and technicians.

• Facilitate the development of revised and new diagnostic products by owning process development from concept generation through transfer to manufacturing.

• Provide technical direction and oversight during the design and optimization of manufacturing processes.

• Enable collaboration with cross functional teams to establish process specifications and quality standards, ensuring alignment with best practices.

• Drive continuous improvement, utilizing Lean/Six Sigma principles to enhance product quality and increase manufacturing efficiency.

• Oversee process risk assessments, failure mode analysis (FMEA), and ensure root cause analysis is completed and mitigations are implemented.

• Design and manage the procedure for process transfer to the manufacturing operation ensuring knowledge transfer and operational capability.

• Foster a culture of knowledge sharing, mentoring, and continuous technical development.

• Mentor personnel to build individual and team capability.

• Performs other work-related duties as assigned.

The Individual

Required:

• Bachelor's degree in chemical engineering or scientific field. Master's degree in chemical engineering preferred, or related scientific field.

• Minimum of 7-10 years' experience in process engineering, with a strong technical background in the fields of diagnostics, biochemistry, or immunochemistry.

• Proven leadership experience and a track record of effectively managing technical teams that deliver bottom line results.

• Expertise in Lean/ Six Sigma methodologies and process optimization.

• Comprehensive understanding of regulatory compliance standards (e.g., FDA, ISO) with the ability to ensure technical compliance.

• Exceptional 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 Excel and Minitab.

The Work Environment

The work environment characteristics are representative of an office, laboratory, and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Essential functions are subject to change as other duties may be assigned.

Salary Transparency

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 that facts and circumstances of each case. Salary range for this position is $94,000 to $159,000 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 their 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 recruiting@quidelortho.com.

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