Principal Quality Engineer

Regulatory Toolkit; Roseville (CA); On-site; USD 135,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with employer match

Paid parental leave

Holiday and vacation accruals

Job summary

Penumbra, Inc. in Roseville, CA seeks a Principal Quality Engineer to drive quality improvement across Operations and champion systematic problem solving. You will lead NCRs/CAPAs, develop CTQ flowdowns, and architect scalable quality systems leveraging SPC, analytics, and automation.

The role requires 7+ years in medical device quality engineering and a strong foundation in LeanSixSigma, FDA QSR, and ISO 13485. Travel and lab work may be required.

Qualifications

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related discipline preferred); advanced degrees strongly preferred.
• 7+ years of experience in Quality Engineering, Continuous Improvement, or Manufacturing Engineering within the medical device industry.
• Experience in Lean and Six Sigma methodologies, leading large-scale continuous improvement, Cost of Quality reduction, or CTQ deployment programs.
• Expert‑level understanding of FDA QSR and ISO 13485 in a manufacturing context.
• Proven ability to lead cross‑functional teams through complex technical challenges and strategic quality initiatives.
• Advanced data analysis, statistical modeling, and decision‑making skills.
• ASQ CQE, CSSBB, or equivalent advanced quality certification.
• Deep expertise in 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-paced environment while influencing long-term quality strategy.

Responsibilities

• Lead cross‑functional continuous improvement initiatives focused on reducing Cost of Poor Quality, improving process capability, and strengthening CTQ/Quality performance across manufacturing operations.
• Identify, quantify, and prioritize systemic quality improvement opportunities using data‑driven methods, advanced analytics, and structured problem‑solving frameworks.
• Own complex NCRs and CAPAs, and participate in NCR boards.
• Develop and deploy CTQ flowdowns, ensuring alignment between product requirements, process controls, and inspection strategies.
• Architect and optimize quality monitoring systems, including predictive analytics, SPC, and automated data visualization tools.
• Lead high‑complexity problem‑solving efforts using 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, and risk‑based acceptance strategies.
• Champion Lean, Six Sigma, and operational excellence methodologies, setting direction for waste reduction, variation control, and process robustness.
• Influence long‑term quality strategy, including technology adoption, digital quality transformation, and advanced analytics integration.
• Train and mentor Quality Engineers, elevating technical capability and fostering a culture of scientific thinking and continuous improvement.

Skills

Quality Engineering

Continuous Improvement

Lean Six Sigma

Statistical Analysis

DOE / Experimental Design

Education

Bachelor's degree in Engineering

Advanced degree preferred

Tools

Statistical Process Control

Automation systems

Quality systems software

Job description

General Summary

As 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 Responsibilities

• Leadcross-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 boards
• Developanddeploy 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 Qualifications

• Bachelor’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 Experience

• ASQ 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, CA

Annual Base Salary Range:

$135,000 to $175,000

We 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 environments

• Business travel from 0% – 10%

• Potential exposure to bloodborne pathogens

• Requires lifting and moving up to 25 pounds

• Must be ableto move between buildings and floors

• Must be ableto remain stationary and use standard office equipment for extended periods

• Mustbe ableto read, prepare emails, and produce documents and spreadsheets

• Must be ableto move within the office and access files or supplies as needed

• Must be ableto communicate and exchangeaccurateinformation with employees at all levels

What 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 to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.