Process Engineering Manager, Pilot Manufacturing & NPI

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

Benefits offered by this job

Full benefits

Growth opportunities

Tuition reimbursement

Career development

Job summary

Dexcom is hiring a Process Engineering Manager in San Diego to lead a team of engineers and scientists, developing and scaling manufacturing processes for new products in a regulated environment.

You will drive process development, DOE studies, and data-driven improvements, oversee pilot-line transfer to manufacturing, and collaborate with R&D, Quality, and Operations to ensure design controls and FDA/ISO compliance. The role also emphasizes mentorship, safety, and quality across the site.

Qualifications

• Experience leading engineers and scientists in manufacturing environments.
• Strong knowledge of GMP/GLP and regulated medical device operations.
• Experience with DMAIC problem-solving and lean manufacturing.
• Familiarity with FDA 21 CFR 820 and ISO 13485 is preferred.

Responsibilities

• Lead process development and characterization for pilot manufacturing.
• Define DOE to characterize processes and optimize performance.
• Oversee transfer of processes and equipment from development to pilot operations.
• Collaborate with R&D, Quality, and Operations to align on risk management and validation strategies.
• Provide hands-on technical guidance for manufacturing workflows and equipment.
• Mentor engineering staff and drive continuous improvement initiatives.
• Ensure compliance with safety, environmental, and quality standards.

Skills

Leadership

DMAIC

Lean manufacturing

Project management

Statistical analysis

Cross-functional collaboration

Education

Bachelor’s degree in a technical discipline

Tools

Gauge R&R

Cp/Cpk

SPC

DOE

IQ/OQ/PQ

Job description

Dexcom is hiring a Process Engineering Manager in San Diego to lead a team of engineers and scientists, developing and scaling manufacturing processes for new products in a regulated environment.

You will drive process development, DOE studies, and data-driven improvements, oversee pilot-line transfer to manufacturing, and collaborate with R&D, Quality, and Operations to ensure design controls and FDA/ISO compliance. The role also emphasizes mentorship, safety, and quality across the site.