Senior/Staff Engineer, Process Development

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Responsibilities:

• 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.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Requirements:

• Typically requires a minimum of 5-8 years of related experience with a Bachelor’s degree.

• Degree in Bioengineering, Systems Engineering, Industrial Engineering, Mechanical Engineering or related field

• 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

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.

The estimated base salary range for the Senior/Staff Engineer, Process Development role based in the United States of America is: $86,500 - $129,700. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an