How You'll Contribute
- Provide subject matter expertise with external/internal audits, design of experiments, process validations, statistics, test method validations, measurement system analysis, sterilization validations, new product development, and risk.
- Collaborate cross-functionally with R&D and Manufacturing Engineering teams to define product quality that meets design and process requirements.
- Support new product launches into pilot production ensuring they meet Penumbra’s quality standards.
- Work with suppliers to continually improve technical processes and ensure reliability and implement inspections that meet Penumbra's quality standards.
- Manage the Key Performance Indicators (KPIs) for assigned product families and functional production areas.
- Partner with cross-functional team on projects and other initiatives as needed.
- Assess, develop, evaluate, implement, and maintain process control systems.
- Hire, develop, and evaluate personnel to ensure individual and team success.
What You Bring
- Versatility, flexibility, and willingness to work within a dynamic environment.
- The ability to present issues, plans, and objectives in a clear, compelling way, both verbally and through documentation.
- Lead and collaborate with Engineering teams on common initiatives and/or product line support.
- Knowledge of applicable regulations and standards, e.g. QSR, ISO 13485.
- Bachelor’s degree required in Engineering (Mechanical, Biomedical, or Materials preferred).
- Minimum of 5 years of relevant experience in a regulated industry, 2+ years of managerial experience.
- Solid knowledge of sterilization and biocompatibility.
- Working knowledge of data collection, data analysis/evaluation, and scientific methodology.
- Class III (preferred) or II medical device experience. Catheter experience helpful.
- Previous manufacturing engineering or process development experience 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.