Staff Manufacturing Engineer: Pilot-Scale & Process

RXinsider LTD.; San Diego, Northern (CA, KY); Hybrid; USD 111,000 - 185,000; Full time

Benefits offered by this job

Comprehensive benefits

Growth opportunities

Career development programs

Tuition reimbursement

Job summary

Dexcom Corporation in San Diego is seeking a Staff Manufacturing Engineer to support pilot plant operations, drive process improvements, and lead validation activities. You will collaborate across R&D, Manufacturing, Quality, and Supply Chain to enable design changes and new product introductions.

The role emphasizes hands-on expertise in pilot-scale/high-volume manufacturing, IQ/OQ/PQ validation, and data-driven problem solving within a regulated quality environment.

Qualifications

• Experience in pilot-scale or high-volume manufacturing environments.
• Ability to lead process validation and equipment qualification activities.
• Strong background in applying statistics to manufacturing problems.

Responsibilities

• Lead cross-functional development, validation, and implementation of manufacturing processes for new products and changes.
• Drive process capability, quality, and yield improvements using DOE, SPC, Gauge R&R, and root-cause analysis.
• Own IQ/OQ/PQ validation protocols, strategies, and regulatory documentation.
• Provide technical leadership and project management across R&D, Manufacturing, Quality, and Supply Chain.
• Contribute PFMEAs, process specs, validation plans, CAPAs, and change controls within a regulated quality system.
• Mentor engineers and shape long-term process and technology roadmaps.

Skills

Pilot-scale manufacturing

High-volume manufacturing

Process validation

Equipment qualification

Measurement systems

Project management

DOE

SPC

Gauge R&R

Education

Bachelor’s degree in a technical discipline

Master’s degree (preferred)

PhD (relevant field) with experience

Job description

Dexcom Corporation in San Diego is seeking a Staff Manufacturing Engineer to support pilot plant operations, drive process improvements, and lead validation activities. You will collaborate across R&D, Manufacturing, Quality, and Supply Chain to enable design changes and new product introductions.

The role emphasizes hands-on expertise in pilot-scale/high-volume manufacturing, IQ/OQ/PQ validation, and data-driven problem solving within a regulated quality environment.