Process Engineer II

Description

Position Summary

The Process Engineer II is a mid-level role focused on advancing operational excellence through the design, implementation, and refinement of scalable process improvements across laboratory, research, and operations workflows. This engineering role builds upon foundational experience to lead targeted initiatives, support automation integration, and enhance compliance and quality. The Process Engineer II will operate with moderate autonomy while collaborating with cross-functional stakeholders, using data-driven insights and continuous improvement methodologies to optimize performance and support organizational growth.

What you'll be doing:

Process Optimization & Workflow Development

• Independently leads small-to-mid-scale process improvement projects to optimize laboratory, research, and operational workflows.
• Develop, implement, and validate process enhancements that align with regulatory expectations and business goals.
• Facilitate process mapping, root cause analysis, and corrective/preventive actions for workflow inefficiencies.
• Support or co-lead automation and systems integration projects aimed at improving scalability, consistency, and efficiency.
• Contribute to the development and standardization of technical documentation, including SOPs, protocols, and reports.
• Track and analyze operational data and KPIs to inform continuous improvement efforts.

Technical Problem-Solving & Data-Driven Improvements

• Apply intermediate-level data analysis to assess process performance and identify improvement opportunities.
• Assist with troubleshooting and resolving operational deviations, process failures, or performance gaps.
• Evaluate and support the integration of digital tools and automation solutions to enhance throughput and reproducibility.
• Participate in validation activities for new or modified processes, software, and laboratory systems.
• Maintain awareness of emerging technologies, regulatory considerations, and best practices in process engineering.

Cross-Functional Collaboration & Project Execution

• Work closely with Laboratory Operations, Pathology Operations, IT, Research, Quality, and Regulatory teams to support successful implementation of process changes.
• Participate in stakeholder meetings to align process improvements with organizational and compliance requirements.
• Provide clear communication of project objectives, milestones, and outcomes to cross-functional collaborators.
• Support or manage small-to-mid-size assigned projects or project components as assigned, ensuring timely execution and alignment with broader engineering strategy.
• Contributes to strategic planning under guidance.

Requirements

What you'll need:

Knowledge, Skills & Experience

• 2-5 years of experience in process engineering, laboratory operations, biotechnology, or a related field.
• Proficiency with Lean, Six Sigma, or other continuous improvement methodologies.
• Experience with data analysis tools and workflow modeling software (e.g., Excel, JMP, Python, MATLAB, or similar).
• Solid understanding of process development, process mapping, and validation principles.
• Ability to interpret operational data, conduct root cause analysis, and propose actionable solutions.
• Exposure to laboratory automation systems, digital process tools, and/or regulated environments preferred.
• Effective written and verbal communication skills for both technical documentation and cross-functional engagement.
• Strong organizational skills and ability to manage multiple projects in a dynamic, fast-paced setting.
• Comfortable working across laboratory, research, and office environments, occasionally performing hands-on assessments.
• Working knowledge of regulatory guidance and compliance expectations (e.g., CLIA, CAP, FDA, ISO 13485) to ensure alignment of process improvements with quality and compliance standards.
• Strong analytical and problem-solving skills to assess inefficiencies, conduct root cause analyses, and develop effective solutions.
• Ability to lead, mentor, and provide technical guidance to junior engineers or team members as needed.

Education, Certifications, and Licensures

• Bachelor's degree in Biomedical Engineering, Process Engineering, Industrial Engineering, or a related field required.
• • Master's degree in a related discipline is a plus.
• Lean Six Sigma Yellow Belt or equivalent coursework preferred (Green Belt a plus).
• Additional certifications in continuous improvement or project management are desirable but not required.

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.