Senior Quality Engineer - Catheters
Penumbra, Alameda, CA
Innovative Medical Devices
What You'll Work On
- Represent Quality Engineering on New Product Development (NPD) cross-functional teams, interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
- Review and approve engineering change orders on assigned projects and product lines.
- Plan, design, and implement test methods, including test equipment, for inspection of product.
- Evaluate, update, and improve difficult manufacturing processes and engineering systems for assigned product lines.
- Work with suppliers to continually improve technical processes, reliability, and inspections to meet Penumbra's quality standards.
- Take the lead on drafting and implementing risk analysis documentation for new and current products with identified hazards and harms.
- Provide leadership and guidance, in the scope of quality systems, to 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.
- Provides leadership and mentoring to more junior staff. May supervise junior engineers.
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.
- Solid knowledge of sterilization, biocompatibility, and transportation and shelf life standards
- Working knowledge of data collection, data analysis, and evaluation, and scientific method.
- Bachelor's degree in an engineering or scientific field, plus 4-6 years of experience in biomedical, mechanical, chemical, or materials engineering.
- R&D or new product development experience helpful.·
- ASQ CQE preferred.
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 TODAY Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on interventional therapies. Penumbra designs, develops, manufactures and markets innovative devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral 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.
Want to learn more about Penumbra? Visit Penumbra's website.
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