Principal Quality Engineer, Global CI - Med Devices

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

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