Process Engineer III

CND Life Sciences; Scottsdale (AZ); On-site; USD 120,000 - 150,000; Full time

Job summary

CND Life Sciences in Scottsdale, AZ, is seeking a Process Engineer III to lead high‑impact process improvements across lab, office and production workflows. You will design, validate and scale automation, map processes, and drive CAPA programs while ensuring regulatory and quality compliance.

This role includes mentoring junior engineers and partnering with IT, Quality, and R&D to deliver reliable, reproducible results.

Qualifications

• Bachelor’s degree required in biomedical/related engineering field.
• 5–8 years’ experience in process engineering or biotech settings.
• Strong Lean Six Sigma and continuous improvement background.
• Experience leading cross‑functional projects and CAPA programs.
• Hands‑on data analysis using statistical tools (Python, JMP, Minitab, MATLAB).
• Familiarity with CLIA/CAP/FDA/ISO 13485 compliance is preferred.

Responsibilities

• Lead high‑impact process improvement initiatives across labs and offices.
• Design, implement, and validate automation strategies for scalability.
• Facilitate process mapping, root cause analysis, and CAPA development.
• Use KPIs to drive optimization with cross‑functional teams.
• Develop SOPs, validation protocols, and technical reports for compliance.
• Manage complex projects from automation rollout to large validation efforts.
• Provide mentorship to junior engineers and coordinate with QA, IT, R&D.

Skills

Process engineering

Continuous improvement

Lean Six Sigma

Project management

Data analysis

Python

MATLAB

JMP

Minitab

Arena

Regulatory knowledge

Education

Bachelor’s degree in Biomedical Engineering or related field

Master’s degree in engineering or related discipline

Certifications in process engineering or project management

Tools

Python

JMP

Minitab

MATLAB

Arena

Job description

***This role is onsite only in Scottsdale, AZ***

Position Summary

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 promote 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.
• 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 promote 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 & Experience

• 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, and 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.
• 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.

Our Mission

Since our founding, CND Life Sciences has been on a mission to advance the care of patients who face the potential diagnosis of a neurodegenerative disease. With long careers in research and clinical care, our founders set out to unlock deeper stories within the skin by detecting key pathological markers in the peripheral nervous system that had been previously out of reach.

Our Core Values

• CND maintains core values that guide our work and mission every day.
• Great science. It’s the foundation of everything we do.
• Patients first. There is a patient hoping for answers behind every test we perform – we never forget that.
• Clinician-minded. We are founded by physicians and dedicated to helping clinicians care for patients – we embrace this responsibility.
• Quality core. We adhere to high laboratory standards and quality practices – it’s the only way to operate.
• Always thinking. We are relentless in determining how we can innovate and do better – it’s just in our DNA.
• Respect. We hold our employees, customers, partners, and suppliers in high regard – we succeed when we are aligned.

CND Life Sciences is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.