Manager - Process Engineering

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

Job summary

Dexcom is seeking a Process Engineering Manager to lead development, characterization, and pilot manufacturing of new products in a regulated environment.

Role focuses on DOE studies, data-driven improvements, and cross-functional collaboration with R&D, Quality, and Operations to ensure robust processes and compliant design controls.

Qualifications

• Bachelor’s degree in a technical discipline with 8–12 years of industry experience.
• 2–5 years of prior management or lead experience is preferred.
• Experience in regulated GMP/GLP environments and quality systems.

Responsibilities

• Lead process development, process characterization, and support pilot manufacturing.
• Define and oversee 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 improvements.
• Oversee transfer and sustaining of processes, test methods, and equipment.
• Collaborate with R&D, Quality, and Operations on validation strategies.
• Provide hands-on technical guidance in manufacturing workflows and equipment.
• Champion NPI roadmaps and growth of technical talent.

Skills

DMAIC

Lean manufacturing

GMP/GLP

FDA 21 CFR 820

ISO 13485

Project management

Cross-functional leadership

Education

Bachelor’s degree in technical discipline

Tools

Statistical analysis tools

Gauge R&R

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. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

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.

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.

To link to the Machine-Readable Files, see the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

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.

Where you come in:

• 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:

• 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.

Salary: $122,500.00 - $204,100.00 #DexcomUS

Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.