The Staff Engineer, Process Development (CLIA Lab) will work on the development and sustainment of our deployed clinical diagnostic products. The primary function of this position will be supporting system implementation, engineering and sustainment of our clinical diagnostic pipeline(s). The role will work closely with operations, product development, software development groups, and quality assurance. The ideal candidate will have experience interfacing with development teams and facilitating the import of lab protocols from product development into a clinical laboratory. Furthermore, the candidate should have analytical skills and interest in interpreting data to drive process optimization and QC. Experience in molecular biology methods for nucleic acid applications, sequencing, and liquid handler automation would be beneficial. Immediate application is establishing and sustaining a scalable Covid-19 testing workflow.
- Work with and sometimes lead cross functional teams to implement new clinical tests, support process changes, or troubleshoot processes within the clinical laboratory.
- Design and execute controlled experiments to optimize processes to achieve commercial levels of stability, robustness, and performance
- Optimize processes to improve throughput, turnaround time, and performance of workflows
- Identify risk and provide recommendations for risk mitigation in area of responsibility and at project level.
- Own a large subsystem or workflow, without needing oversight.
- Use systematic problem-solving methods to troubleshoot complex issues related to workflow quality, stability and robustness. Recommend and drive corrective and preventive actions.
- Analyze trends in throughput, turnaround time, and performance tied to process workflow; provide guidance on improvements and cost reduction activities
- Supports Clinical laboratory and product development process engineering needs.
- Participates in identifying new technologies and leads technical execution
- Be a technical and integration representative for Operations on cross functional initiatives.
- Works closely with scientists, bioinformatics, engineering, software, quality, and commercial teams to develop, transfer, and sustain new products into the Clinical laboratory.
- Manage vendors on a technical level for development and sustainment needs
- Mentors peers and supporting engineers on technical skills in one’s area of expertise
- Able to create requirements, plan activities and contribute to project scope, and prioritization of activities/assignments to supporting team members.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
- Bachelor’s degree with at least 8 years of related experience, or Master’s degree with at least 6 years of related experience, or PhD with at least 3 years of related experience
- Field of study in Bioengineering, Systems Engineering, Industrial Engineering, or Mechanical Engineering preferred
- Good interdepartmental communication skills and ability to interact effectively across groups within a fast-paced environment are required
- Experience with process development, process integration, scale-up and sustainment of high volume clinical production lines
- Experience using statistical methods for yield improvement and process stability (e.g. Cp/CpK, Pareto Analysis, Design of Experiment (DOE), Statistical Process Control (SPC))
- Knowledge of Gage R&R, optical measurement devices, test method development, and mechanical modeling are preferred
- Six Sigma Blackbelt/Greenbelt certification preferred
- Experienced in defining requirements for lab workflows and LIMS systems.
- Experience with NGS technology strongly preferred
- Familiar with automated systems and liquid handlers such as Agilent Bravo, Tecan and Hamilton preferred
- Background with validation and verification processes in a regulated laboratory.
- Ability to think innovatively toward solving problems effectively and efficiently.
- Excellent problem solving and analytical skills.
- Working knowledge of CLIA/CAP, NYSDOH, and ISO13485 guidelines a plus
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
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