As a Quality Engineer at Penumbra, you will participate in all aspects of product 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 identifying problems and determining the appropriate course of action. You will be looked to for ensuring compliance and building a culture of quality within your project teams.
What You'll Work On
- Represent Quality Engineering on process improvement projects, interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
- Initiate and implement engineering change orders on assigned projects and product lines.
- Implement test methods, including test equipment, for inspection of product.
- Troubleshoot, update, and improve difficult manufacturing processes for assigned product lines.
- Work with suppliers on Supplier Corrective Actions and ensure they will meet Penumbra's quality standards.
- Evaluate and update risk analysis documentation for new and current products with identified hazards and harms.
- Ensure compliance within designated projects and product lines.
- Lead nonconforming report investigations and recommend appropriate corrective actions.
- Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement and close CAPAs.
- Apply statistical rationale to plan, analyze, and interpret engineering test data collected during new testing.
What You Bring
- A passion for detailed analysis and problem solving.
- A knack for solving mechanical problems effectively.
- The desire to be part of a great team and to represent Quality Engineering on cross-functional technical teams.
- The ability to present issues, plans and objectives in a clear, compelling way, both orally and in writing.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Broad knowledge of applicable regulations and standards, e.g. QSR, ISO 13485.
- Working knowledge of sterilization, biocompatibility, and transportation and shelf life standards are preferred.
- Working knowledge of data collection, data analysis, and evaluation, and scientific method.
- Bachelor's degree in an engineering or scientific field, plus 1 - 5 years of experience in biomedical, mechanical, chemical, or materials engineering.
- Manufacturing, R&D or new product development experience helpful.
What We Offer
- A collaborative teamwork environment where learning is constant and performance is rewarded.
- The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases.
- A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets innovative products and has a broad portfolio that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and vascular. Penumbra sells its products to hospitals 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, disability or protected veteran status.