Sr. Manager, Production Engineering

POSITION SUMMARY:

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The Sr. Manager, Production Engineering will lead a newly formed team to deploy and maintain complex automated work cells, fleets of automated liquid handlers, and hundreds of scientific instruments and related equipment to support the processing of samples in a clinical diagnostics laboratory environment. This role will assume responsibility for all equipment at Natera’s Austin laboratory facility and will collaborate heavily with the scientific and engineering development teams as well as their laboratory operations customers.  In addition to the constant deployment of new instrumentation and a focus on improving equipment uptime, this role will be responsible for partnering broadly to identify, implement, and support continuous improvement efforts to our automated and non-automated workflows in order to increase the efficiency of our laboratory processes.

 

PRIMARY RESPONSIBILITIES:

• Deploy and maintain fully automated robotic work cells and liquid handling robots

• Build, motivate, and develop a team of production engineers with specializations in liquid handling and equipment support/maintenance in support of a high-throughput 24/7 laboratory operation

• Act as the primary responsible individual while leading a team of engineers and coordinating with outside vendors in the troubleshooting all instrumentation, equipment, and control software related issues across the Austin site

• Oversee the deployment, testing, qualification (IQ/OQ/PQ), and user training of all automated systems and laboratory equipment 

• Develop testing and re-validation procedures to rapidly troubleshoot issues and release reliable instruments back to production teams

• Develop and improve KPI tracking and performance related to uptime, team performance, equipment maintenance, SLA adherence, and utilization while collaborating with colleagues at Natera’s San Carlos facility to maintain consistency in processes and procedures across both sites.

• Collaborate with various teams to develop and maintain documentation including SOPs, IQ/OQ/PQ, work instructions, calibration/PM, and training for instrumentation and equipment in a regulated clinical laboratory environment

• Ensure workflows are in compliance with FDA, CAP, CLIA and State (CA, MD, NY, etc) regulations while supporting and acting as the Equipment representative in quality/partner audits

• Identify, evaluate ROI, develop, and deploy continuous improvements to liquid handling and integrated work cell robots and associated systems with a focus on improving uptime and efficiency

• Perform duties as assigned

 

QUALIFICATIONS:

• BS degree in a Life/Physical Science or Engineering discipline, with 12+ years of related industry experience

• 8+ years of experience working with laboratory automation and integrated laboratory equipment in a service and support role

• 4+ years managing a team in a service and support function

• Experience deploying hardware into a production environment with robust verification/validation requirements (cGMP, CLIA, CAP, ISO 13485/9001) and stringent IQ/OQ/PQ

 

KNOWLEDGE, SKILLS, AND ABILITIES:

• Expert in providing service and support across a variety of complex instrumentation including: Hamilton, Tecan, and integrated robotics platforms

• Ability to write scripts for liquid handling robots and to train others

• Ability to program and troubleshoot complex robotic scheduling software (Cellario, Momentum, Green Button Go etc.)

• Strong mechanical, electrical, and software troubleshooting abilities

• Ability to effectively communicate and collaborate with scientific, engineering, operations, and regulatory teams as well as external parties 

• Demonstrated success in developing and implementing equipment management and support ticketing systems

• Strong analytical skills to build/develop/improve KPI monitoring and report data to management

• Ability to roll up your sleeves and help your team with hands-on troubleshooting

• Ability to utilize and teach Lean Manufacturing and Six Sigma methodologies

 

PHYSICAL DEMANDS & WORK ENVIRONMENT:

 

• Duties may require working outside normal working hours at times (onsite and remotely) to keep our facility running and coordinate with your team

• This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material. 

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and s