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.