Process Engineering Manager - Medical Device GMP Leader

RXinsider LTD.; San Diego, Northern (CA, KY); Hybrid; USD 123,000 - 204,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Tuition reimbursement

Career development programs

Job summary

Dexcom Corporation is seeking a Process Engineering Manager in San Diego to lead process development, characterization, and pilot manufacturing. You will ensure processes are robust, compliant with FDA and ISO 13485, and drive improvements using DOE and statistical methods.

You will mentor engineers, collaborate with R&D, Quality, and Operations, and help advance NPI roadmaps while maintaining safety and quality standards in a regulated environment.

Qualifications

• Bachelor’s degree in a technical discipline; 8–12 years of industry experience.
• 2–5 years of previous management or lead experience.

Responsibilities

• Lead process development, process characterization, and support pilot manufacturing; ensure processes are robust and compliant with Design Controls, ISO 13485, FDA requirements, and regulatory standards.
• Define and oversee Design of Experiments (DOE) to characterize processes, validate changes, and optimize performance using statistical tools.
• Manage the documentation and execution of experimental requests on pilot manufacturing lines with proper process controls and traceability.
• Monitor pilot line performance; identify trends and drive improvements through data-driven decisions.
• Interpret build data and process metrics to assess variability and implement corrective actions using advanced statistics.
• Oversee transfer and sustaining of processes, test methods, and equipment from development into pilot operations.
• Collaborate cross-functionally with R&D, Quality, and Operations on process specs, risk management (PFMEA), and validation strategies (IQ/OQ/PQ).
• Provide hands-on technical guidance for manufacturing workflows and pilot-scale facilities in a regulated environment.
• Champion New Product Introduction (NPI) roadmaps and initiatives; mentor engineering talent.

Skills

Process engineering

Leadership

DOE

Statistical analysis

Cross-functional collaboration

Education

Bachelor’s degree in a technical discipline

Tools

Gauge R&R

Cp/Cpk

SPC

Job description

Dexcom Corporation is seeking a Process Engineering Manager in San Diego to lead process development, characterization, and pilot manufacturing. You will ensure processes are robust, compliant with FDA and ISO 13485, and drive improvements using DOE and statistical methods.

You will mentor engineers, collaborate with R&D, Quality, and Operations, and help advance NPI roadmaps while maintaining safety and quality standards in a regulated environment.