Sr. Process Development & Automation Engineer

Position Overview

The Senior Engineer, Process Development & Automation leads, manages, implements, and provides technical engineering support for a variety of process automation hardware, software applications, and laboratory instruments. This position collaborates cross-functionally with internal and external partners to enhance existing workflows and develop new automated workflows in a complex, rapidly evolving clinical laboratory.

Engineering Design & Project Leadership

• Develop process architectures and functional specifications based on user and workflow requirements.
• Lead planning activities and conduct complex engineering design, platform eligibility testing, systems integration, and performance testing.
• Manage moderately complex projects and initiatives, applying project leadership skills in planning, delegating, influencing, and managing priorities.
• Provide input for project design and development, and accurately estimate task effort.
• Take scientific bench protocols from the bench to the automation system.
• Contribute creative, practical ideas and insights on new technologies, testing methodologies, applications, techniques, and procedures.

Instrumentation & Automation Lifecycle

• Work with project managers and cross-functional teams on user requirements, factory acceptance tests, validation planning, site acceptance tests, pre-installation planning, initial installation, setup, maintenance, and improvement for new or upgraded instrumentation and automation systems.
• Lead recommendations and implementation of changes that ensure ongoing high-quality performance of laboratory equipment.
• Lead technical investigation and troubleshooting of laboratory systems.
• Support and respond to complex system problems, counseling internal and external vendors and Laboratory Service Engineers on corrective and preventive actions.
• Lead continuous improvement projects that drive cost reduction and lab efficiency.

Quality, Safety & Compliance

• Ensure new and existing instrumentation meets safety requirements and compliance standards.
• Maintain records and follow laboratory procedures to meet regulatory requirements such as FDA, CLIA, and/or CAP.
• Support and comply with the company's Quality Management System policies and procedures.

Collaboration, Mentorship & Communication

• Mentor and provide technical guidance to service engineers, laboratory technicians, junior engineers, and other members of the Process Development & Automation team.
• Actively and constructively contribute to others' designs through design reviews within the organization.
• Present factual information and convey very complex information clearly, in both written and oral form.
• Influence others, gain acceptance, and build consensus.

Minimum Qualifications

• Bachelor's degree in Engineering or a related field; or an Associate's degree in Engineering, Technology, Electronics, or a similar field plus 2 years of experience.
• 6+ years of experience in engineering or a relevant industry.
• Advanced knowledge of engineering theories, practices, and procedures.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Bachelor's degree in Engineering or a related field and 10+ years of relevant experience; or an Associate's degree with 12+ years of relevant industry experience.
• Technical proficiency and experience in automation, system development, and integration in a laboratory environment.
• Experience in process optimization involving complex workflows with both system equipment and software components.
• Experience working in a CAP/CLIA and/or other regulated production environment.
• Advanced knowledge of databases, laboratory information management systems, and other file management applications.