Principal Quality Engineer - Medical Devices, Data-Driven

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) with employer match

Paid parental leave

Paid holidays

Vacation time

Paid sick time

Job summary

Penumbra, Inc. is seeking a Principal Quality Engineer to lead quality improvement across Operations. You will apply advanced analytics to strengthen process capability, optimize inspection systems, and drive continuous improvement beyond manufacturing boundaries.

You will influence quality strategy, champion Lean Six Sigma, and mentor Quality Engineers, shaping a culture of operational excellence across the organization in Alameda, CA.

Qualifications

• Structured Quality Engineering approaches and methodologies.
• FDA QSR and ISO 13485 experience in manufacturing.
• Proven ability to lead cross-functional teams through complex challenges.

Responsibilities

• Lead cross-functional continuous improvement initiatives to reduce Cost of Poor Quality.
• Quantify and prioritize systemic quality opportunities using data-driven methods.
• Develop CTQ flowdowns aligning product requirements and controls.
• Architect and optimize quality monitoring systems with predictive analytics.
• Lead high-complexity problem solving using advanced statistical methods.
• Improve inspection systems, test methods, and measurement capability.
• Champion Lean, Six Sigma and operational excellence practices.
• Shape long-term quality strategy and digital quality transformation.
• Train and mentor Quality Engineers to elevate technical capability.

Skills

Quality leadership

Statistical analysis

DOE and regression

CTQ deployment

Cross-functional leadership

Lean Six Sigma

Data-driven decision making

Education

Bachelor’s degree in Engineering

Advanced degree preferred

Job description

Penumbra, Inc. is seeking a Principal Quality Engineer to lead quality improvement across Operations. You will apply advanced analytics to strengthen process capability, optimize inspection systems, and drive continuous improvement beyond manufacturing boundaries.

You will influence quality strategy, champion Lean Six Sigma, and mentor Quality Engineers, shaping a culture of operational excellence across the organization in Alameda, CA.