Principal Process Development Engineer - Data Analytics

Principal Data Analytics Engineer 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. Responsibilities Serve as technical authority for advanced data analysis in support of engineering, manufacturing, and quality initiatives across high-volume medical device programs. Collaborate closely with R&D, Quality, Regulatory, Supply Chain, and Manufacturing to analyze complex data sets, design and interpret DOEs, and drive statistically driven conclusions informing critical technical and business decisions. Support engineering and project teams in creating robust protocols and final reports across the product lifecycle from advanced development through commercialization. Conduct characterization studies, validations, and root cause investigations enabling defensible, data‑driven paths forward in a regulated environment. Lead data‑driven root cause investigations and translate findings into clear recommendations ensuring analyses meet GMP, ISO 13485, and FDA QSR expectations. Play a lead role in technology transfer programs spanning process design, validation, and analytical method transfer in cGMP, FDA, and ISO environments. Mentor engineers on statistical thinking, experimental design, and execution. Qualifications MS in Statistics, Engineering, Applied Mathematics, Data Science or related field. 15+ years of related experience or a Master’s degree and 10+ years, or PhD and 7+ years of experience in regulated manufacturing environments. Proven experience applying advanced analytics in high‑volume medical device manufacturing. Six Sigma or Design for Six Sigma Blackbelt certification (e.g., ASQ). Deep expertise in device process validation: IQ/OQ/PQ, process characterization, DOEs, statistical analysis, risk management within FDA‑regulated environment. Proficiency with Python, R, SQL, JMP, Minitab or equivalent tools. Strong understanding of requirements trace, functional decomposition, risk management (SHA, DFMEA, PFMEA). Strong communication skills – able to present complex analytical results to technical, non‑technical and executive audiences. Experience and Education Requirements Typically requires a Bachelor’s degree in a technical discipline with a minimum of 15+ years related experience. Alternatively, a Master’s degree and 10+ years of equivalent industry experience or a PhD and 7+ years of experience. Location, Travel, Flex Workplace Location and Travel: 25–50% travel required. Primary location is a home office; must live within commuting distance (~75 miles) of Dexcom site. Flex Workplace: Primary location will be a home office. Will not have an assigned workstation; work with manager to determine office visit needs. Salary: $164,200.00 – $273,600.00. Benefits Full and comprehensive benefits program. Career development through in‑house learning programs and tuition reimbursement. Access to life‑changing CGM technology and community engagement. Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or disability. Reasonable accommodations may be made for individuals with disabilities. #J-18808-Ljbffr