Principal Quality Engineer, Medical Devices – CI

Penumbra, Inc.; 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

Equity program

Job summary

Penumbra, Inc. in California is seeking a Principal Quality Engineer to drive quality improvement across Operations, applying deep analytical expertise to strengthen process capability, optimize inspection, and elevate quality performance through structured continuous improvement.

You will influence quality strategy, design scalable quality systems to prevent defects, and lead cross-functional teams to mitigate risks and advance manufacturing robustness.

Qualifications

• Bachelor's degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related) preferred.
• 7+ years of quality engineering, continuous improvement, or manufacturing engineering in the medical device industry.
• Expert-level understanding of FDA QSR and ISO 13485 in a manufacturing context.

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.
• 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, 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.

Skills

Quality engineering experience

Cross-functional leadership

Analytical skills

Statistical methods

Problem solving

Education

Bachelor's degree in Engineering

Advanced degree preferred

Job description

Penumbra, Inc. in California is seeking a Principal Quality Engineer to drive quality improvement across Operations, applying deep analytical expertise to strengthen process capability, optimize inspection, and elevate quality performance through structured continuous improvement.

You will influence quality strategy, design scalable quality systems to prevent defects, and lead cross-functional teams to mitigate risks and advance manufacturing robustness.