Senior Process Engineer (R&D)

The OpportunityQuidelOrtho 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 RoleAt QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Process Engineer supporting assay development. We are seeking a talented Senior Process Engineer in Rochester, NY to join us in our mission to create world class diagnostic solutions. As a Senior Process Engineer in our assay development group, you will play a critical role in the design, development, and optimization of manufacturing processes for our diagnostic products. You will work closely with a multidisciplinary team of scientists, engineers, and quality assurance professionals to ensure the quality, scalability, and capability of our diagnostic products. This individual will function as a technical project leader, as well as performing laboratory work.This position will be onsite full-time in Rochester, NY. The Responsibilities * Design and optimize manufacturing processes for diagnostic reagents and related products. * Lead a process improvement team - develop strategy and work plan to achieve project objectives. * Implement Lean/Six Sigma principles to enhance product quality and increase manufacturing efficiency. * Conduct process risk assessments, failure mode analysis (FMEA), and root cause analysis to identify and resolve issues. * Transfer processes to the manufacturing operation and verify process capability against design requirements. * Maintain accurate records in accordance with the QuidelOrtho Quality System. * Maintain core expertise in the fields of surface modification, formulation, and coating. * Maintain a safe working environment through the proactive identification of hazards and risks. * Collaborate to help a team or work group achieve its goals. * Perform other work-related duties as assigned.The IndividualRequired: * Education: Bachelor's or Master's in chemical engineering or related technical field. * Experience: Minimum 5 years' experience in process engineering, preferably in diagnostics, pharmaceuticals or biotechnology. * Strong problem-solving skills, including root cause analysis and data driven decision making. * Excellent teamwork and communication skills. * Knowledge of safe chemical and biological handling. * Ability to travel (<10%). * This position is not currently eligible for visa sponsorship.Preferred: * PhD in chemical engineering or related technical field. * Proficiency in Lean/ Six Sigma methodologies and process optimization. * Familiarity with regulatory compliance standards (FDA, GMP, ISO). * Knowledge of statistical tools and data analysis software such as Minitab, JMP, R, Java, Python. * A strong self-motivated team player with a proactive attitude is highly desired.The Key Working RelationshipsInternal Partners: * Collaborate with cross functional teams to develop and improve process specifications and quality standards. * Train and mentor junior engineers and scientists, fostering a culture of continuous improvement and knowledge sharing. * Interface with Operations and Tech Transfer colleagues to ensure processes are implemented seamlessly.External Partners: *