Manager of Process Engineering jobs in United States
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Dexcom · 18 hours ago

Manager of Process Engineering

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). 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.

DiabetesHealth DiagnosticsMedical DeviceSensor
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H1B Sponsor Likelynote

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 DevelopmentDesign of Experiments (DOE)Statistical Analysis ToolsGMP/GLP OperationsFDA ComplianceLean ManufacturingProject ManagementMentoring Engineering TalentCross-Functional CollaborationTechnical LeadershipCommunication 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

Preferred

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

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.

Company

Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.

H1B Sponsorship

Dexcom has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (41)
2023 (67)
2022 (75)
2021 (49)
2020 (36)

Funding

Current Stage
Public Company
Total Funding
$2.16B
Key Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M

Leadership Team

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Jacob Leach
Chief Operating Officer
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Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
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Company data provided by crunchbase