Medical Device Principal Quality Engineer (Global Continuous Improvement)

Penumbra, Inc.; San Francisco (CA); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Benefits package

Equity program

Vacation days

Parental leave

Medical coverage

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Principal Quality Engineer to lead quality improvement across Operations.

You will apply deep analytical expertise to strengthen process capability, optimize inspection systems, and elevate quality performance through structured improvement methodologies. In this role you will influence quality strategy, design scalable quality systems to prevent defects, mentor Quality Engineers, and drive cross‑functional collaboration with Manufacturing, Industrial

Qualifications

• 7+ years of experience in Quality Engineering, Continuous Improvement, or Manufacturing Engineering in medical devices.
• Experience with Lean and Six Sigma, CTQ deployment, or Cost of Quality reduction.
• Knowledge of FDA QSR and ISO 13485 in manufacturing contexts.

Responsibilities

• Lead cross-functional continuous improvement initiatives to reduce Cost of Poor Quality and strengthen CTQ performance.
• Identify quantify and prioritize systemic quality improvement opportunities using data-driven methods.
• Develop and deploy CTQ flowdowns aligning product requirements with process controls and inspection strategies.
• Architect and optimize quality monitoring systems including SPC and automated data visualization.
• Lead complex problem-solving using DOE, regression modeling, and multivariate analysis.
• Drive continuous improvement of inspection systems, sampling optimization, and risk-based acceptance strategies.
• Champion Lean, Six Sigma, and operational excellence methodologies across manufacturing operations.
• Influence long-term quality strategy including digital quality transformation and analytics integration.
• Train and mentor Quality Engineers to elevate technical capability.

Skills

Quality Engineering

Statistical Analysis

DOE

Process Capability

Quality Systems (FDA QSR/ISO 13485)

Cross-functional Leadership

Data Visualization

Education

Bachelor's degree in Engineering

Advanced degree preferred

Tools

Minitab

SQL

Python (data analysis)

Job description

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.

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.

Position Qualifications

• 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 Experience

• 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.

Location: Alameda, CA

Annual Base Salary: $150,000 to $195,000

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 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

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.