New · posted Oct 23
Penumbra · Medical Devices
Principal Quality Engineer
- Alameda, CA
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
As a Principal Quality Engineer, you will serve as a technical leader driving quality improvement across Operations. You will apply deep analytical expertise to strengthen process capability, optimize inspection and monitoring systems, and elevate quality performance through structured continuous improvement methodologies.
This role requires structured Quality Engineering approaches, strong engineering analysis and methodologies, statistical experience, and the ability to architect scalable Quality Engineering systems that prevent defects, reduce variation, and enhance long‑term manufacturing robustness. You will influence quality strategy, develop new approaches to systemic quality challenges, and champion a culture of operational excellence across the organization.
Working cross‑functionally with 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 are identified and executed with rigor.
What you need
Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related discipline preferred); advanced degree 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.
Preferred Experiencenice to have
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.
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.
What you'll do
Specific Duties and Responsibilities
Lead cross-functional continuous improvement initiatives focused on reducing Cost of Poor Quality, improving process capability, and strengthening Critical to Quality performance across manufacturing operations.
Identify, quantify, and prioritize systemic quality improvement opportunities using data‑driven methods, advanced analytics, and structured problem‑solving frameworks.
Develop and deploy CTQ flowdowns, ensuring alignment between product requirements, process controls, and inspection strategies.
Architect and optimize quality monitoring systems, including predictive analytics, statistical process control, 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.
Pay
$150,000 – $195,000 a year
Employer providedAnnual Base Salary Range: $150,000 to $195,000
• 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.
Where you'll work
Alameda, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Alameda, CAWorking 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 able to move between buildings and floors
Must be able to remain stationary and use standard office equipment for extended periods
Must be able to read, prepare emails, and produce documents and spreadsheets
Must be able to move within the office and access files or supplies as needed
Must be able to communicate and exchange accurate information with employees at all levels
Equal opportunity, accessibility and legal noticesPenumbra's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 45% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California91 roles publishing pay
Senior & Principal roles in the US313 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $150,000 | — | $195,000 |
| California (middle half) | $115,750 | $135,500 | $157,250 |
| All US (middle half) | $102,500 | $119,000 | $137,500 |
This role: Penumbra's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Penumbra's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods8
- Quality systems and risk8
- Collaboration and leadership7
- GMP and compliance4
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Penumbra on Regulatory Jobs
- 13
- Open roles
- 12
- Distinct roles
- 2
- Locations
By discipline
- Quality11 85%
- Regulatory2 15%
By level
- Senior & Principal7 54%
- Associate & Specialist5 38%
- Manager1 8%
More roles at Penumbra
- View role
Senior Supplier Quality & Compliance Analyst
Alameda, CA · HybridSenior & PrincipalMedical Devices$113K–$150K
- View role
Senior Supplier Quality Engineer – Supplier Development
Alameda, CA · HybridSenior & PrincipalMedical Devices$119K–$166K
- View role
Quality Engineer II - Catheters
Roseville, CAAssociate & SpecialistMedical Devices$85K–$114K
- View role
Quality Engineer II
Alameda, CASenior & PrincipalMedical Devices$95K–$127K
Similar Quality Assurance roles elsewhere
- View role
Sr. Quality Engineer
iRhythmCypress, CASenior & PrincipalMedical Devices$99K–$129K
- View role
Sr Quality Engineer I - Manufacturing
Tandem Diabetes CareSan Diego, CASenior & PrincipalMedical Devices$110K–$121K
- View role
Sr. Quality Engineer, Failure Analysis
Becton DickinsonIrvine, CASenior & PrincipalMedical Devices$106K–$169K
- View role
Senior Quality Engineer
Becton DickinsonBrea, CASenior & PrincipalMedical Devices$106K–$169K
Principal Quality Engineer at Penumbra
Open until filled. $150K–$195K a year, employer provided.