South San Francisco, CA

Senior Process Engineer

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Position description

The Process Engineer is an enthusiastic, self-motivated person with great communication skills who can support Manufacturing and Clinical Operations through continuous improvement of operations processes and infrastructure. As a Process Engineer at Counsyl, you will bring your Systems Engineering background to help the Automation and Operations teams drive improvements to the quality, efficiency, and capacity of our fully-integrated clinical sequencing laboratory. You will be heavily involved in mapping and modeling how we get patient samples to informative health results, informing and driving continuous improvements projects across multiple groups.

The Process / Manufacturing Engineer will demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below. The candidate will be comfortable creating / revising processes and documentation within a value added QMS based on CLIA/CAP, ISO 13485:2016 and FDA QSR regulations. 

What You'll Do

  • Creating / Developing, updating, reviewing, Standard operating procedures and supporting work instructions based in CLIA, CAP, CLEP, ISO 13485, FDA Quality System Regulations
  • Manufacturing and Clinical Operations workflow analysis, cost and process improvements to improve efficiency and remove waste from the systems
  • Assure product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes
  • Active input into the Verification and Validation program for equipment and assays
  • Make biological sample handling processes more efficient in a state-of-the-art medical diagnostics facility
  • Design and execute data gathering exercises with the aim of improving new and existing protocols for use in a high-throughput automated lab
  • Create a broad set of analytical tools and use them to make targeted improvements to automated systems across multiple labs / environments
  • Maintain expertise on alternate methods, techniques and best practices used in the field; routinely benchmark process performance
  • Handle multiple projects, seeing obvious overlaps to make the implementation process more efficient and standardized
  • Gather requirements, create specifications, and document appropriately for the engineering teams
  • Support production activities; offer insight into troubleshooting methodology and problem resolution with complex instrumentation, systems or processes
  • Aid software integration of all the products and protocols you develop: In a large-scale, distributed, fully-automated genome factory, centralization of data is critical
  • Supervise and train junior team members in best practices and standardized methodologies
  • Work with Counsyl’s custom robotic platforms and learn what it means to be on the bleeding edge of technology

About You

  • Minimum, B.S./B.A. in Computer Science, Engineering, Chemistry or Life Science 
  • 5+ years as a Process / Manufacturing Engineer or equivalent with experience in a medical device or clinical laboratory environment  
  • Complete understanding of a regulated equipment and assay qualification program: IOPQ, FAT, SAT, Verification and Validation
  • Critical to have a strong foundation in statistical analysis
  • Mechanical, Electrical, Software, or Process - you can follow a broad range of topics within the engineering family, and know how to spot the gaps between the disciplines 
  • You can pull apart and identify the critical components of production workflows at a glance - creating FMEA, CTQ, and 5S schemas are nothing new
  • Practical experience with: 
  • Equipment and material qualification
  • Automation of processes
  • Computerized system validation
  • Process validation and biological assay validation
  • Calibration and Preventive Maintenance
  • Statistical Process Control
  • Operations Excellence / Visual Factory
  • cGMP, ISO 13485 and ISO 14971
  • Experience in CLIA regulated clinical labs / Biotech start-up/fast growth company or similar working environment very helpful
  • Advanced degrees will be favored

About Counsyl

Counsyl is a health technology company that offers DNA screening for diseases that can impact men, women and their children. The Counsyl philosophy is simple: screen for diseases where advanced knowledge makes a difference in health outcomes, whether it’s changing a behavior, pursuing preventative measures, or simply preparing for what lies ahead.

The Counsyl team includes an accomplished group of problem-solvers — top engineers, scientists, and designers — who are taking the lead on building the modern clinical laboratory. Scientific rigor, custom robotics, and software are at the heart of every Counsyl product, resulting in better, faster and more affordable screens that are broadly accessible. Beyond the laboratory, Counsyl offers doctors and patients a technology platform for results delivery in real time, with on-demand access to board-certified genetic counselors.

Counsyl has screened more than 750,000 patients and served more than 10,000 health care professionals in its CLIA-certified, CAP-accredited and NYS CLEP-permitted clinical laboratory. The company has raised a total of $102 million and is privately backed by Pilot Growth Equity, Goldman Sachs Asset Management, Founders Fund, Felicis Ventures, David Drummond, and other high profile investors.

Interview process

Counsyl is driven by some of the brightest people in the industry. Our interview process is geared to ensure that we continue to hire the very best. We are an equal opportunity employer and value diversity at our company.

Our interview process is composed of practical and situational interviews in a series of settings spanning Skype, practical exams, and in-person meetings. Our goal is to gauge both your ability to succeed in the first 90 days as well as your capacity to scale with us as we grow.

Why Counsyl?

Throughout it all, we are looking to understand why you are driven to be a part of our company. Specifically, we want to know how you identify with our mission and will contribute to our team.

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