The Process Engineer III is a senior-level engineering professional responsible for leading high-impact process improvement initiatives, optimizing workflows, and implementing scalable, sustainable solutions across multiple functions within the organization. This role applies advanced technical knowledge, data analytics, systems-thinking, and cross-functional collaboration to drive operational excellence and efficiency while ensuring regulatory and quality compliance. As a subject matter expert in continuous improvement methodologies, automation integration, and process engineering best practices, the Process Engineer III also provides mentorship and technical leadership to junior team members.

Job Responsibilities:

Drive the identification and resolution of inefficiencies across laboratory and office workflows, ensuring all process improvements align with organizational goals and compliance standards. Design, implement, and validate advanced process enhancements and automation strategies that prmote scalability, operational efficiency, and reproducibility. Lead continuous improvement efforts by facilitating process mapping, root cause analyses, corrective action planning, and the development of robust control systems. Leverage operational data, KPIs, and performance metrics to assess workflow effectiveness and identify opportunities for ongoing optimization in collaboration with cross-functional teams. Develop and approve technical documentation, including SOPs, validation protocols, and technical reports, to support standardization and regulatory compliance. Manage complex, cross-functional projects, ranging from automation rollouts to large-scale process validation, ensuring timely delivery of key milestones and results. Utilize advanced analytical tools, modeling techniques, and simulation software to evaluate and enhance process performance. Lead root cause investigations and implement corrective and preventive actions (CAPAs) to resolve process deviations and strengthen process controls. Champion the integration of automation technologies, digital tools, and control systems that improve throughput, consistency, and data traceability. Stay current on emerging technologies, trends, and best practices in process engineering, automation, and anatomic pathology operations to proactively drive innovation. Oversee and contribute to validation activities for new or modified processes, systems, and equipment to ensure alignment with regulatory expectations and internal quality standards. Serve as a strategic technical advisor and liaison across Lab Operations, Pathology, Research & Development, IT, Quality, Regulatory and administrative teams to facilitate the successful implementation of process improvements. Engage stakeholders at all levels to ensure that process changes address operational needs while meeting quality and compliance requirements. Represent the Process Engineering function in internal technical reviews, vendor evaluations , and cross-functional workstreams. Deliver clear, impactful presentations and technical communications to senior leadership, project teams, and external partners to support decision-making and foster alignment. Perform other responsibilities and special assignments as directed. Knowledge, Skills & Abilities: 5-8 years of progressively responsible experience in process engineering, laboratory operations, biotechnology, or related technical disciplines. Proven track record of leading end-to-end process improvement initiatives, integrating automation, and driving continuous improvement within highly regulated environments. Deep understanding of Lean, Six Sigma, and other process optimization methodologies, with demonstrated success applying these tools to enhance efficiency and reduce variability. Strong experience managing complex, cross-functional projects, including validation, system implementation and operational change management. Proficient in data analysis and statistical tools such as Python, MATLAB, JMP, Minitab and Arena, with the ability to translate data into actionable insights. Hands-on familiarity with automation platforms, digital workflow tools, and process control systems used in laboratory or biotech settings.. Working knowledge of regulatory and quality standards including CLIA, CAP, FDA, ISO 13485, with a clear understanding of how to align process improvements with compliance expectations. Strong analytical and critical thinking skills with the ability to identify inefficiencies, perform root cause analysis, and implement scalable, sustainable solutions. Effective communicator with the ability to write clear technical documentation and deliver impactful presentations to both technical and executive audiences Demonstrated ability to mentor and support junior engineers or cross-functional teammates, fostering collaboration and technical growth. Highly organized, detail-oriented, and capable of balancing multiple priorities in a fast-paced, evolving environment. Comfortable working in laboratory, production, and office settings, with a willingness to engage directly in hands-on process assessments when needed. Education, Certifications & Licensures: Bachelor's degree in Biomedical Engineering, Process Engineering, Industrial Engineering, or a related field required. Master's degree in engineering, systems engineering, biotechnology, or a related discipline is preferred. Lean Six Sigma Green Belt certification is preferred. Additional certifications in process engineering, continuous improvement, or project management, such as PMP, ASQ-CQE are also desirable. Other: Combination of seated and standing work to complete the core functions of the role. Adherence to company safety policy. Ability to work onsite at the Company's Scottsdale, AZ headquarters approximately five (5) days a week.