Dexcom · 1 day ago
Principal Process Development Engineer
San Diego, California
Full-time
Onsite
Senior Level, Lead/Staff
$164K/yr - $274K/yr
7+ years expDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Principal Process Development Engineer will lead the translation of novel materials and chemistries into scalable manufacturing solutions, collaborating closely with various teams to ensure successful product introductions and lifecycle management.
DiabetesHealth DiagnosticsMedical DeviceSensor
Responsibilities
You will support a range of programs from new product introductions and launches to scale up, on-market, and end of life management. Leading collaborative efforts and directing material selection activities, ensuring seamless progression, timely feedback, and optimization, while fostering teamwork and accountability
Anticipate and respond to changing market requirements by positioning the business to proactively address emerging regulatory and stainability trends and market shifts; maintained business continuity, customer satisfaction, and competitive margin profile/performance differentiation
Establish manufacturing readiness plans for chemical and polymer unit operations and associated in‑process controls, align process requirements, materials specifications, and analytical test strategies ahead of transfer
Define process performance targets and critical quality attributes and process parameters using first‑principles materials science and structured experimentation DOEs, supported by statistical methods
Lead technology transfer from R&D to Operations, including development of process flow maps and control strategies, coordinate equipment user requirement documents, with robust validation to meet cGMP/FDA/ISO requirements
Partner with Analytical Development/Quality to transfer and validate analytical and assay methods into QC environments, including robust test method development and validation
Drive materials selection and supplier process qualification ensuring material lots and supply chain are compatible with scale‑up and compliance requirements to support sustained, robust global manufacturing
Architect scale‑up roadmaps from lab/pilot to high‑volume manufacturing, balancing process physics, materials behavior (structure‑processing‑property relationships), and production constraints. Implement data pipelines for capability monitoring and continuous improvement
Lead root‑cause investigations and failure analysis across material–process–product interactions. Then deploy corrective/preventive actions that harden process robustness and product reliability
Provide technical leadership to internal teams and external manufacturing partners
Qualification
Required
PhD or MS in Chemical Engineering, Materials/Polymer Science, Analytical Chemistry, Pharmaceutical Sciences, or related field (PhD Preferred)
Typically requires a Bachelor's degree in a technical discipline, and a minimum of 15+ years related experience or a Master's degree and 10+ years equivalent industry experience or a PhD and 7+ years of experience
Recognized subject matter expertise in chemical and polymer systems with demonstrated mastery of structure–processing–property relationships and their application to high volume, highly regulated medical device/diagnostics manufacturing
Proven leadership of technology transfer programs spanning process design, validation, and analytical method transfer; comfortable navigating device/diagnostic cGMP, FDA, and ISO environments
Track record of cross functional influence, from executive level communication to coaching engineers
Stay abreast of advancing technologies and processes, and the competitive landscape, proactively seeking out opportunities for implementation
Drive innovation in approach, processes, and methodologies while ensuring adherence to company, customer, and industry requirements and specifications
Engage in an environment of personal and team accountability, that is conducive to the development and growth of the team through mentoring and coaching
Demonstrated success in NPI and manufacturing scale‑up for chemical/polymer processes, including validation to cGMP and ISO standards; familiarity with combination product interfaces is a plus
Proficiency with Six Sigma/Lean, statistical tools, and manufacturing execution documentation (pFMEA, control plans, sampling plans)
Preferred
Diagnostics/pharma/biotech experience, especially in analytical development and method transfer supporting device/assay workflows
Benefits
A full and comprehensive benefits program.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
Company
Dexcom
Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.
10001+ employees
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 CompanyTotal Funding
$2.16BKey Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M
Leadership Team
Jake Leach
Chief Operating Officer
Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
Recent News
The Motley Fool
2025-12-30
Company data provided by crunchbase