Manager - Process Engineering

Dexcom • San Diego, CA

8d • $122,500 - $204,100 • Onsite

About The Position

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. 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.

Requirements

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

Nice To Haves

• STEM degree with proven ability to work hands-on in a fast-pasted environment with competing priorities.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager