Lead Pilot Process Engineering - Medical Devices

Dexcom Inc.; San Diego (CA); On-site; USD 123,000 - 204,000; Full time

Benefits offered by this job

CGM technology exposure

Comprehensive benefits

Global growth opportunities

Career development programs

Innovative culture

Job summary

Dexcom Inc. in San Diego seeks a Process Engineering Manager to lead a team of engineers and scientists through process development, DOE execution, and pilot manufacturing transfer. You will ensure robust, compliant processes aligned with Design Controls and regulatory requirements, while guiding improvements with advanced statistics.

You will mentor talent, collaborate across R&D, Quality, and Operations, and champion NPI roadmaps and innovation in a fast-paced environment.

Qualifications

• Bachelor’s degree in a technical discipline plus 8–12 years of industry experience.
• 2–5 years of prior management or lead experience.
• Experience with GMP/GLP in regulated environments preferred (medical device/pharma).

Responsibilities

• Lead process development, process characterization, and support pilot manufacturing.
• Define and oversee Design of Experiments (DOE) to characterize processes and optimize performance.
• Manage documentation and execution of experimental requests on pilot lines.
• Monitor pilot line performance, identify trends, and drive data-driven improvements.
• Interpret build data and metrics to assess variability and implement corrective actions.
• Oversee transfer and sustaining of processes, test methods, and equipment into pilot operations.
• Collaborate with R&D, Quality, and Operations on risk management and validation strategies.
• Provide hands-on technical guidance for manufacturing workflows and pilot-scale facilities.
• Champion NPI roadmaps and innovation.
• Select, develop, and mentor engineering talent.
• Ensure safety, environmental, and quality standards; support regulatory submissions.

Skills

Process leadership

DOE development

Statistical tools

GMP/GLP experience

FDA compliance

Cross-functional collaboration

Lean manufacturing

Project management

Education

Bachelor’s degree in a technical discipline

Tools

Gauge R&R

Cp/Cpk

SPC

Job description

Dexcom Inc. in San Diego seeks a Process Engineering Manager to lead a team of engineers and scientists through process development, DOE execution, and pilot manufacturing transfer. You will ensure robust, compliant processes aligned with Design Controls and regulatory requirements, while guiding improvements with advanced statistics.

You will mentor talent, collaborate across R&D, Quality, and Operations, and champion NPI roadmaps and innovation in a fast-paced environment.