Principal Quality Engineer

Penumbra • Alameda, CA

5d • Onsite

About The Position

The Principal Quality Engineer serves as a technical leader driving quality improvement across Operations. The role applies deep analytical expertise to strengthen process capability, optimize inspection and monitoring systems, and improve quality performance through structured continuous-improvement methodologies. It uses Quality Engineering approaches, engineering analysis, statistical methods, and scalable systems to prevent defects, reduce variation, and improve long-term manufacturing robustness.

The position influences quality strategy, develops approaches to systemic quality challenges, and champions operational excellence across the organization. It works cross-functionally with Manufacturing Engineering, Industrial Engineering, Operations Leadership, and R&D to build quality proactively into processes, mitigate risks, and identify and execute improvement opportunities.

The position is based in Alameda, California. Working conditions include general office, laboratory, and cleanroom environments, with business travel of 0%–10%.

Requirements

• Bachelor’s degree in Engineering; Biomedical, Mechanical, Materials, Chemical, or a related discipline is preferred.
• Seven or more years of experience in Quality Engineering, Continuous Improvement, or Manufacturing Engineering within the medical device industry.
• Experience with Lean and Six Sigma methodologies and 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.

Nice To Haves

• An advanced degree is strongly preferred.
• 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 to reduce Cost of Poor Quality, improve process capability, and strengthen 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 that align 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 complex problem-solving efforts using advanced statistical and scientific methods, including DOE, regression modeling, multivariate analysis, and reliability modeling.
• Improve 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 integration of advanced analytics.
• Train and mentor Quality Engineers, elevating technical capability and fostering scientific thinking and continuous improvement.

Benefits

• Competitive compensation package and equity program, when applicable.
• Medical, dental, vision, life, AD&D, and short- and long-term disability insurance for eligible employees.
• 401(k) with employer match.
• Paid parental leave.
• Eleven paid company holidays per year.
• A minimum of fifteen days of accrued vacation per year, increasing with tenure.
• Paid sick time in compliance with applicable laws.
• Collaborative teamwork environment with ongoing learning and performance rewards.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal