{"schemaVersion":"jobsearcher.job.v1","id":"93941f848cc6496d61c80fa1","url":"https://jobsearcher.com/jobs/93941f848cc6496d61c80fa1","canonicalUrl":"https://jobsearcher.com/jobs/93941f848cc6496d61c80fa1","title":"Principal Process Development Engineer - Data Analytics","description":"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.\nResponsibilities Serve as technical authority for advanced data analysis in support of engineering, manufacturing, and quality initiatives across high-volume medical device programs.\nCollaborate 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.\nSupport engineering and project teams in creating robust protocols and final reports across the product lifecycle from advanced development through commercialization.\nConduct characterization studies, validations, and root cause investigations enabling defensible, data‑driven paths forward in a regulated environment.\nLead data‑driven root cause investigations and translate findings into clear recommendations ensuring analyses meet GMP, ISO 13485, and FDA QSR expectations.\nPlay a lead role in technology transfer programs spanning process design, validation, and analytical method transfer in cGMP, FDA, and ISO environments.\nMentor engineers on statistical thinking, experimental design, and execution.\nQualifications MS in Statistics, Engineering, Applied Mathematics, Data Science or related field.\n15+ years of related experience or a Master’s degree and 10+ years, or PhD and 7+ years of experience in regulated manufacturing environments.\nProven experience applying advanced analytics in high‑volume medical device manufacturing.\nSix Sigma or Design for Six Sigma Blackbelt certification (e.g., ASQ).\nDeep expertise in device process validation: IQ/OQ/PQ, process characterization, DOEs, statistical analysis, risk management within FDA‑regulated environment.\nProficiency with Python, R, SQL, JMP, Minitab or equivalent tools.\nStrong understanding of requirements trace, functional decomposition, risk management (SHA, DFMEA, PFMEA).\nStrong communication skills – able to present complex analytical results to technical, non‑technical and executive audiences.\nExperience 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.\nLocation, 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.\nFlex Workplace: Primary location will be a home office. Will not have an assigned workstation; work with manager to determine office visit needs.\nSalary: $164,200.00 – $273,600.00.\nBenefits Full and comprehensive benefits program.\nCareer development through in‑house learning programs and tuition reimbursement.\nAccess to life‑changing CGM technology and community engagement.\nEqual 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.\n\n#J-18808-Ljbffr","company":"1 Dexcom","rawCompany":"1 dexcom","city":"San Diego","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-06-17T04:22:22.306Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Principal Process Development Engineer - Data Analytics","description":"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.\nResponsibilities Serve as technical authority for advanced data analysis in support of engineering, manufacturing, and quality initiatives across high-volume medical device programs.\nCollaborate 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.\nSupport engineering and project teams in creating robust protocols and final reports across the product lifecycle from advanced development through commercialization.\nConduct characterization studies, validations, and root cause investigations enabling defensible, data‑driven paths forward in a regulated environment.\nLead data‑driven root cause investigations and translate findings into clear recommendations ensuring analyses meet GMP, ISO 13485, and FDA QSR expectations.\nPlay a lead role in technology transfer programs spanning process design, validation, and analytical method transfer in cGMP, FDA, and ISO environments.\nMentor engineers on statistical thinking, experimental design, and execution.\nQualifications MS in Statistics, Engineering, Applied Mathematics, Data Science or related field.\n15+ years of related experience or a Master’s degree and 10+ years, or PhD and 7+ years of experience in regulated manufacturing environments.\nProven experience applying advanced analytics in high‑volume medical device manufacturing.\nSix Sigma or Design for Six Sigma Blackbelt certification (e.g., ASQ).\nDeep expertise in device process validation: IQ/OQ/PQ, process characterization, DOEs, statistical analysis, risk management within FDA‑regulated environment.\nProficiency with Python, R, SQL, JMP, Minitab or equivalent tools.\nStrong understanding of requirements trace, functional decomposition, risk management (SHA, DFMEA, PFMEA).\nStrong communication skills – able to present complex analytical results to technical, non‑technical and executive audiences.\nExperience 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.\nLocation, 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.\nFlex Workplace: Primary location will be a home office. Will not have an assigned workstation; work with manager to determine office visit needs.\nSalary: $164,200.00 – $273,600.00.\nBenefits Full and comprehensive benefits program.\nCareer development through in‑house learning programs and tuition reimbursement.\nAccess to life‑changing CGM technology and community engagement.\nEqual 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.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T04:22:22.306Z","dateModified":"2026-06-17T04:22:22.306Z","hiringOrganization":{"@type":"Organization","name":"1 Dexcom","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"San Diego","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"93941f848cc6496d61c80fa1"},"url":"https://jobsearcher.com/jobs/93941f848cc6496d61c80fa1"}}