Dexcom · 1 day ago
Sr. Staff IT Validation Engineer
Mesa, Arizona
Full-time
Onsite
Senior Level, Lead/Staff
$135K/yr - $225K/yr
8+ years expDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Sr. Staff IT Validation Engineer will provide guidance for validation and testing support for complex automated information technology applications, interfacing with various functions to ensure compliance and quality in IT projects.
DiabetesHealth DiagnosticsMedical DeviceSensor
Responsibilities
Act as subject matter expert to develop and support verification and validation activities for Enterprise Systems (e.g. Camstar/MES systems, ERP systems, QMS systems) and Process (IQ/OQ/PQ/PPQ), Test Method Validations, Computer Software Assurance methodology and Validation Master Planning
Provide QA & QC requirements for IT & OT systems
Provide guidance / expertise on GxP risk-assessment at system level, functionality level, and data element level
Provide guidance / expertise on EU MDR as well as 21 CFR 820 & 21 CFR Part 11
Actively participate as a core advisor to the IT/OT teams
Effectively communicates with broad Dexcom team and upper level management on project progress and challenges
Applies risk management, validation, sample size, and external standards review and implementation activities
Applies techniques like six sigma and Total Quality Management to improve Dexcom operations
Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples could include equipment, process, software and test method validation, auditing, calibrations, CAPA, customer complaint processing, document control, nonconforming materials, process controls, receiving inspection, training
Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs
Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools
Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab)
Assumes and performs other duties as assigned
Qualification
Required
Experience with validation of enterprise computer systems as used in pharmaceutical and/or medical device environments, such as Electronic Document Management Systems, Manufacturing Execution Systems, Enterprise Resource Planning Systems, Clinical Data Management Systems, and/or Laboratory Information Management Systems
Must have a thorough understanding of GxP-related business processes and Quality Systems, and FDA electronic records/signature requirements and computer validation expectations
Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems)
Experience with providing risk-based quality guidance for IT & OT systems, ideally with experience in med device / discrete manufacturing
Knowledge and understanding of FDA Computer System Assurance (CSA) principles and methodology
Must be able to work independently to perform a project management role within cross-functional teams and with projects of varying degrees of complexity. Prior managerial skills preferred
Excellent written and verbal communication skills, with hands-on experience creating CSV documentation
Excellent organizational skills and attention to detail
Typically requires a Bachelor's degree in a technical discipline, and a minimum of 13+ years related experience or a Master's degree and 8+ years equivalent industry experience or a PhD and 5+ years of experience
Preferred
Proven experience with all levels of SDLC artifacts for 21 CFR Part 11 impacted systems
Proven expertise in delivering full cycle CSV programs to deliver 21 CFR Part 11 compliance across both IT systems and OT (Operations Technology) systems (such as MES, PLC)
Proven expertise creating and executing Computer System Validation Plans & Protocols
Proven managerial skills in leading teams, and cross-functional collaboration
Medical device or regulated industry experience strongly preferred
ASQ SQE (Software Quality Engineer) certification
Expertise in 21 CFR Part 11
Familiarity with 21 CFR 820 a plus
Experienced in validating manufacturing automation solutions including MES, SCADA, PLC, Data Historians, EBR
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.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
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
Jacob Leach
Chief Operating Officer
Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
Recent News
2026-01-16
Medical Device Network
2026-01-15
Company data provided by crunchbase