Manufacturing Engineer (Medical Devices)

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.

Internal Title: Product Engineer 2

Position Summary:

Responsible for supporting product lifecycle activities, including new product introduction, product transfer, and ongoing manufacturing operations. This role ensures product quality, yield, and compliance through engineering evaluation, troubleshooting, and continuous improvement initiatives. Collaborates cross-functionally to drive process enhancements, cost optimization, and operational excellence, enabling smooth transition from design to production and sustaining high-performance standards throughout the product lifecycle.

Position Responsibilities:

Common Responsibilities:

• Support and drive product transfer into manufacturing.
• Perform data trending and analysis.
• Apply FMEA, DOE, and statistical analysis to optimize product quality and reduce costs.
• Drive process improvements, cost reduction, and product sustaining activities.
• Manage Engineering Change Request and Notifications (CRs and CNs), including updates to work instructions and test requirements.
• Support documentation: engineering drawings, BOMs, test reports, assembly procedures, and validation plans.
• Participate in continuous improvement initiatives and operational excellence programs.
• Frequent cross-functional collaboration and occasional travel to other sites.

Discipline-Specific Responsibilities:

Process Engineering

• Lead small-scale continuous improvement projects in manufacturing operations.
• Drive measurable improvements in quality, material control, throughput, flexibility, and cost.
• Apply Lean tools and methods in problem-solving and process optimization.
• Conduct cycle time studies, line balancing, and assist in design of experiments using statistical approaches.
• Develop data collection tools and support KPI tracking for improvement projects.
• Support manufacturing engineers in implementing supervisory-level control solutions.

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.

Position Requirements:

• Bachelor’s Degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.
• Experience in Lean Kaizen events and process improvement.
• Strong process engineering and data analysis skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Effective communication and presentation skills.
• Six Sigma Green Belt preferred.
• Experience in FDA/ISO13485 environment is a plus.
• Familiarity with SAP ERP is 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.