Principal Quality Engineer

Roseville, CAEngineering – Quality Engineers /External /On-siteGeneral SummaryAs a Principal Quality Engineer, you will serve as a technical leaderdrivingqualityimprovement across Operations. You will apply deep analyticalexpertiseto strengthen process capability,optimizeinspection and monitoring systems, and elevate quality performance through structured continuous improvement methodologies.This role requiresstructured Quality Engineering approaches,strongengineeringanalysis and methodologies, statisticalexperience, and the ability to architect scalableQualityEngineeringsystems that prevent defects, reduce variation, and enhancelong‑termmanufacturing robustness. You will influence quality strategy, developnew approachesto systemic quality challenges, and champion a culture of operational excellence across the organization.Workingcross‑functionallywith Manufacturing Engineering, Industrial Engineering, Operations Leadership, and R&D, you will ensure that quality is proactively designed into processes, risks are systematically mitigated, and improvement opportunities areidentifiedand executed with rigor.Specific Duties and ResponsibilitiesLeadcross-functionalcontinuous improvement initiatives focused on reducing Cost of Poor Quality, improving process capability, and strengthening CriticaltoQualityperformance across manufacturing operations.Identify, quantify, and prioritize systemic quality improvement opportunities usingdata‑drivenmethods, advanced analytics, and structuredproblem‑solvingframeworks.Own complex NCRs and CAPAs, and participate in NCR boardsDevelopanddeploy CTQflowdowns, ensuring alignment between product requirements, process controls, and inspection strategies.Architect andoptimizequality monitoring systems, including predictive analytics, statistical process control, and automated data visualization tools.Leadhigh‑complexityproblem-solvingeffortsusing advanced statistical and scientific methods (DOE, regression modeling, multivariate analysis, reliability modeling).Drive continuous improvement of inspection systems, test methods, and measurement capability, including automation, sampling optimization, andrisk‑basedacceptance strategies.Champion Lean, Six Sigma, and operational excellence methodologies, setting direction for waste reduction, variation control, and process robustness.Influencelong‑termquality strategy, including technology adoption, digital quality transformation, and advanced analytics integration.TrainandmentorQuality Engineers, elevating technical capability and fostering a culture of scientific thinking and continuous improvement.Position QualificationsBachelor’s degree in Engineering(Biomedical, Mechanical, Materials, Chemical, or related discipline preferred); advanceddegreestrongly preferred.7+ years of experience in Quality Engineering, Continuous Improvement, or Manufacturing Engineering within the medical device industry.Experiencein Lean and Six Sigma methodologies,leadinglarge‑scalecontinuous improvement,CostofQuality reduction, or CTQ deployment programs.Expert‑levelunderstanding of FDA QSR and ISO 13485 in a manufacturing context.Proven ability to leadcross‑functionalteams through complex technical challenges and strategic quality initiatives.Advanced data analysis, statistical modeling, anddecision‑makingskills.Preferred ExperienceASQ CQE, CSSBB, or equivalent advanced quality certification.Deepexpertisein inspection technologies, destructive testing, sampling theory, and measurement system analysis.Experience implementing automation, digital quality systems, or advanced analytics platforms.Strong collaboration with Manufacturing Engineering, Industrial Engineering, Equipment Engineering, and R&D.Ability to thrive in a dynamic,fast‑pacedenvironment while influencinglong‑termquality strategy.Location: Roseville, CAAnnual Base Salary Range:$135,000 to $175,000We offer a competitive compensation package plus a benefits and equity program, when applicable.Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.Working Conditions:General office, laboratory, and cleanroom environmentsBusiness travel from 0% – 10%Potential exposure to bloodborne pathogensRequires lifting and moving up to 25 poundsMust be ableto move between buildings and floorsMust be ableto remain stationary and use standard office equipment for extended periodsMustbe ableto read, prepare emails, and produce documents and spreadsheetsMust be ableto move within the office and access files or supplies as neededMust be ableto communicate and exchangeaccurateinformation with employees at all levelsWhat We Offer• A collaborative teamwork environment where learning is constant, and performance is rewarded.• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.If you reside in the State of California, please also refer toPenumbra's Privacy Notice for California Residents.For additional information on Penumbra’s commitment to being an equal opportunity employer, please seePenumbra's AAP Policy Statement.