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Dexcom Deutschland GmbH · 16 hours ago

Manager of Process Engineering

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$122K/yr - $204K/yr

8+ years exp

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), aiming to empower people to take control of their health. The Process Engineering Manager will lead a team in developing and characterizing manufacturing processes for new products, ensuring compliance with regulatory standards and driving innovation in a regulated environment.

Medical Device

Responsibilities

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

Qualification

Process DevelopmentFDA ComplianceISO 13485Statistical AnalysisLean ManufacturingDMAIC ProcessProject ManagementSTEM DegreeTeam LeadershipCross-Functional CollaborationCommunication Skills

Required

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

Typically requires a Bachelors degree with 8-12 years of industry experience

2-5 years of previous management or lead experience