Principal Quality Engineer – Medical Devices

Penumbra, Inc.; Roseville (CA); On-site; USD 135,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with employer match

Paid holidays & vacation

Job summary

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

You will apply deep analytical expertise to strengthen process capability, optimize inspection and monitoring systems, and elevate quality performance through structured continuous improvement methodologies. You will influence quality strategy, develop new approaches to systemic challenges, and champion operational excellence across the organization.

Qualifications

• 7+ years in Quality Engineering, Continuous Improvement, or Manufacturing Engineering within medical devices.
• Experience with Lean and Six Sigma, leading large-scale improvement projects.
• Expert understanding of FDA QSR and ISO 13485 in manufacturing.

Responsibilities

• Lead cross-functional improvement initiatives to reduce Cost of Poor Quality and improve CTQ performance.
• Own NCRs and CAPAs; participate in NCR boards.
• Develop and deploy CTQ flowdowns aligning product requirements, process controls, and inspection strategies.
• Architect and optimize quality monitoring systems with predictive analytics and SPC.
• Lead complex problem-solving using DOE, regression, and multivariate analyses.
• Drive continuous improvement of inspection systems, automation, and sampling strategies.
• Champion Lean, Six Sigma, and operational excellence to reduce waste and variation.
• Influence long-term quality strategy and digital quality transformation.
• Mentor Quality Engineers to elevate technical capability and scientific thinking.

Skills

Quality Engineering

Lean Six Sigma

Cross-functional leadership

Statistical analysis

DOE / multivariate analysis

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 in California.

You will apply deep analytical expertise to strengthen process capability, optimize inspection and monitoring systems, and elevate quality performance through structured continuous improvement methodologies. You will influence quality strategy, develop new approaches to systemic challenges, and champion operational excellence across the organization.