Manager - Process Engineering

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

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

Meet The Team

Our Manufacturing Process Engineering team is part of the San Diego Innovation Center of Excellence, driving the development, transfer, and scale-up of manufacturing processes and equipment for new products. In the Pilot Manufacturing environment, we focus on bridging R&D product concepts and full-scale production—developing robust processes, characterizing performance, and ensuring compliance with Design Control requirements.

The Process Engineering Manager plays a critical role in leading technical strategy and execution for process development and characterization, enabling successful commercialization of innovative products within a regulated environment.

Where You Come In

As Process Engineering Manager, you will provide technical leadership to a team of engineers and scientists to:

• Lead process development, process characterization, and support pilot manufacturing, ensuring processes are robust, well-defined, and compliant with Design Controls, ISO 13485, FDA compliance, and regulatory requirements.
• Define and oversee Design of Experiments (DOE) to characterize processes, validate changes, and optimize performance using statistical analysis tools (Gauge R&R, Cp/Cpk, SPC).
• Manage the documentation and execution of experimental requests on pilot manufacturing lines, ensuring proper process controls, traceability, and alignment with product design requirements and Design Development Plans.
• Monitor pilot line performance, identify trends, and drive improvements through data-driven decision-making and continuous improvement strategies.
• Interpret build data and process metrics to assess variability, identify root causes, and implement corrective actions using advanced statistical methods.
• Oversee the transfer and sustaining of processes, test methods, and equipment from development into pilot operations, ensuring product functionality and cost-effectiveness.
• Collaborate cross-functionally with R&D, Quality, and Operations to align on process specifications, risk management (PFMEA), and validation strategies (IQ, OQ, PQ).
• Provide hands-on technical guidance for manufacturing workflows, specialized equipment, analytical testing tools, and pilot-scale facilities within a regulated environment.
• Champion New Product Introduction (NPI) roadmaps and strategies, driving innovation and operational excellence.
• Select, develop, and mentor engineering talent, fostering a culture of technical rigor and collaboration.
• Ensure compliance with safety, environmental, and quality standards across all pilot manufacturing activities, supporting regulatory submissions as needed.

What Makes You Successful

The Process Engineering Manager is responsible to maintain proper product functionality, develop and sustain manufacturing processes, and equipment within the San Diego Manufacturing site through:

• Proven experience managing engineers and scientists, with cross functional disciplines, focused on manufacturing processes, product release testing, and investigations.
• Knowledge of DMAIC process, structure problem solving, lean manufacturing and project management with proven success of implementation.
• Proven engineering experience supporting and managing regulated GMP/GLP operations, preferably in medical device, medical diagnostic, and/or pharmaceutical industries.
• Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems).
• Excellent written and oral skills, driving efficient and effective communication cross functionally.
• Proven ability to collaborate and drive results in a matrix organization.
• Recommended to have a STEM degree with proven ability to work hands-on in a fast-pasted environment with competing priorities.

What You’ll Get

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Travel Required

• 15-25%

Education And Experience

• Typically requires a Bachelor’s degree in a technical discipline with 8-12 years of industry experience
• 2-5 years of previous management or lead experience

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail].

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [e-mail].

AI in Hiring Notice

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

Salary

$122,500.00 - $204,100.00

#DexcomUS