Principal Process Development Engineer - Data Analytics

Meet the team :

We are seeking a Principal Data Analytics Engineer to serve as a technical authority for advanced data analysis in support of engineering, manufacturing, and quality initiatives across high-volume medical device programs.
You will be part of the Global Engineering team within Operations, a team that leads end-to-end technical oversight across external suppliers, contract manufacturers, and specialized automation partners for our wet chemistries, electronics, and hardware systems. You will collaborate closely across R&D, Quality, Regulatory, Supply Chain, and Manufacturing, gaining broad exposure across the full product lifecycle from advance tech development through commercialization.
You will partner with programs and project teams to analyze complex data sets, design and interpret Designs of Experiments (DOEs), and drive statistically driven conclusions that inform critical technical and business decisions.Your work will directly support engineers and project teams in the creation of robust protocols and final reports across the whole of the product lifecycle from advanced development, technology transfer, scaling, and on-market support. This includes characterization studies, validations for products and equipment, and root cause investigations, enabling fast, defensible, data-driven paths forward in a highly regulated environment.

Where you come in :

• 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 data collection and analysis activities, ensuring seamless progression, timely feedback, and optimization, while fostering teamwork and accountability.
• You will partner with engineering, manufacturing, and quality teams as a principal-level analytics expert, analyzing large, complex data sets to drive robust and rapid decision-making.
• You will design, execute, and interpret complex DOEs for product, process, and equipment studies. This includes performing advanced statistical analyses supporting validation, capability, and reliability assessments.
• You will lead data-driven root cause investigations and translate findings into clear recommendations, ensuring analyses meet GMP, ISO 13485, and FDA QSR expectations.
• You will play a lead role in technology transfer programs spanning process design, validation, and analytical method transfer in device/diagnostic cGMP, FDA, and ISO environments.
• You will mentor engineers on statistical thinking and experimental design and execution.

What makes you successful :

• You are a recognized subject matter expert in advanced data analytics methods for complex systems and their application to high volume, highly regulated medical device/diagnostics manufacturing.
• You can leverage your expertise in statistical methods, paired with practical engineering judgment, to enable clear and actionable path forward. You are comfortable challenging assumptions using data with a proven ability to influence decisions through evidence-based analysis.
• You are able to communicate complex analytical results clearly to technical, non-technical, and executive audiences.
• You have a track record of cross-functional influence, from executive-level communication to coaching engineers. You bring clarity to ambiguity and drive decisions that integrate business strategy with technical depth.
• You stay abreast of advancing technologies and processes, and the competitive landscape, proactively seeking out opportunities for implementation.
• You will closely engage with cross-functional partners in manufacturing, R&D, supply chain, and quality assurance.
• You drive innovation in approach, processes, and methodologies while ensuring adherence to company, customer, and industry requirements and specifications. This includes offering recommendations for technology and process solutions to enhance performance and achieve both short-term and long-term objectives.
• You engage in an environment of personal and team accountability, in a way that is conducive to the development and growth of the team through mentoring and coaching.

Key Competencies:

• MS in Statistics, Engineering, Applied Mathematics, Data Science, or related field.
• Proven industry experience applying advanced analytics in regulated manufacturing environments. Strong experience supporting high-volume medical device manufacturing.
• Six Sigma or Design for Six Sigma Blackbelt from an accredited certification body (e.g., ASQ)
• Deep expertise in medical device process validation, including IQ/OQ/PQ execution, process characterization, design of experiments (screening, modeling, optimization), statistical analysis and risk management within FDA-regulated manufacturing environment.
• Versed in a range of statistical analysis and modeling tools such as control charts, capability analysis, regression, ANOVA, and multivariate methods, measurement system analysis (MSA) response surface models, machine learning, etc. Proficiency with Python, R, SQL, JMP, Minitab, or equivalent tools.
• Strong understanding requirements trace, functional decomposition, and risk management (SHA, DFMEA, PFMEA)

What you’ll get:

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefit program.
• 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.

Travel Required:

• 25 to 50%

Experience and Education Requirements:

• 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.

Flex Workplace:

Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).