Medical Device Senior Quality Engineer

General Summary

As a Senior Quality Engineer at Penumbra, you will participate in all aspects of process development, supplier development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will apply your passion for detailed analysis to identify problems and determine the appropriate course of action. You will be looked to for communicating quality objectives and building a culture of quality throughout the company.

What You’ll Work On

• Represent Quality Engineering on cross-functional teams - interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations / Planning, and Marketing.
• Evaluate, analyze, and continuously improve manufacturing processes, quality controls, and engineering systems for assigned product lines.
• Own or review Engineering Change Orders on assigned projects and product lines.
• Plan, design, and implement test / inspection methods, including test / inspection equipment, to achieve product quality control objectives .
• Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards.
• Take the lead on risk analysis and documentation.
• Lead or participate in project teams - coordinating the quality efforts to meet project objectives.
• Plan, schedule, and execute engineering project work to meet business and quality objectives.
• Provide leadership and guidance to ensure assigned projects and product lines are compliant with the quality system and regulations.
• Lead nonconforming report investigations and recommend appropriate corrective actions.
• Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.
• Design experiments and tests, and apply statistical rationale to analyze, and interpret engineering test data
• Provide leadership and mentoring to more junior staff. May supervise junior engineers.

Position Qualifications

Minimum education and experience :

Additional qualifications :

What You'll Bring

Working Conditions

Location and Salary :

What We Offer

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.