Principal Quality Engineer - Medical Devices & Analytics

Penumbra, Inc.; San Francisco (CA); Presencial; USD 150.000 - 195.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D

Disability insurance

401(k) with employer match

Parental leave

Eleven paid company holidays

Vacation accrual

Descripción de la vacante

Penumbra, Inc. in Alameda, CA is seeking a Principal Quality Engineer to serve as a technical leader driving quality improvements across Operations.

You will strengthen process capability, optimize inspection and monitoring systems, and elevate quality performance through structured continuous improvement methods. You will influence quality strategy, develop new approaches to systemic challenges, and champion operational excellence while mentoring Quality Engineers and collaborating with

Formación

• Bachelor’s degree in Engineering; advanced degree preferred.
• 7+ years in Quality Engineering or Manufacturing Engineering in medical devices.
• Lean Six Sigma experience; leading large-scale CI programs.
• FDA QSR and ISO 13485 knowledge in manufacturing.
• Proven ability to lead cross-functional teams through complex challenges.
• Advanced data analysis, statistical modeling, and decision making.

Responsabilidades

• Lead cross-functional CI initiatives to reduce Cost of Poor Quality.
• Quantify and prioritize systemic quality improvements via data-driven methods.
• Develop CTQ flowdowns aligning product requirements and inspection strategies.
• Architect and optimize quality monitoring systems with predictive analytics and SPC.
• Lead complex problem-solving using DOE, regression, and multivariate analysis.
• Improve inspection systems, testing, and measurement capability; automate where possible.
• Champion Lean, Six Sigma and operational excellence across the organization.
• Influence long-term quality strategy including digital quality transformation.
• Train and mentor Quality Engineers to foster scientific thinking.

Educación

Bachelor’s degree in Engineering

Advanced degree

Descripción del empleo

Penumbra, Inc. in Alameda, CA is seeking a Principal Quality Engineer to serve as a technical leader driving quality improvements across Operations.

You will strengthen process capability, optimize inspection and monitoring systems, and elevate quality performance through structured continuous improvement methods. You will influence quality strategy, develop new approaches to systemic challenges, and champion operational excellence while mentoring Quality Engineers and collaborating with