Manufacturing Engineer - Process Validation & Leadership

Dexcom Inc.; San Diego (CA); On-site; USD 111,060 - 185,100; Full time

Job summary

Dexcom Inc. in San Diego invites a senior Manufacturing Engineer to lead cross-functional development, validation, and implementation of scalable manufacturing processes for new products and design changes.

You will drive process capability, quality, and yield improvements using DOE, SPC, Gauge R&R, and robust root-cause analysis, while owning IQ/OQ/PQ validation and related regulatory documentation in a fast-paced, regulated environment.

Qualifications

• Bachelor’s degree in a technical discipline required.
• Master’s degree (preferred) or PhD with corresponding experience as noted in the job description.

Responsibilities

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

Skills

DOE

SPC

Gauge R&R

Root cause analysis

Process validation

Equipment qualification

Education

Bachelor's degree

Master's degree

PhD

Tools

Job description

Dexcom Inc. in San Diego invites a senior Manufacturing Engineer to lead cross-functional development, validation, and implementation of scalable manufacturing processes for new products and design changes.

You will drive process capability, quality, and yield improvements using DOE, SPC, Gauge R&R, and robust root-cause analysis, while owning IQ/OQ/PQ validation and related regulatory documentation in a fast-paced, regulated environment.