Quality Engineering Manager - Catheters
Penumbra, Alameda, CA
Innovative Medical Devices
What Success Looks Like
- As a leader, manage the quality engineering functions of development projects within a multidisciplinary project team
- Mentor and develop cross-functional team members with the mentality that their success is your success
- 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
- Take the lead on continuous improvement initiatives
- With your top notch critical thinking, find ways to make Penumbra's quality system better
- Ensure product quality associated with our most robust array of product lines
- With a high level of customer service, provide engineering support to designated production lines
- Support new product launches into pilot production ensuring they meet Penumbra’s quality standards
- Own the vendor management process to maintain strong relationships with suppliers
- 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
- Assess, develop, evaluate, implement, and maintain process control systems
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 preferred
- Proven track record of working with applicable regulations and standards, e.g. QSR, ISO 13485 required
- Proven work history of growing within an organization, learning its systems, and showing initiative preferred
- Bachelor’s degree required (mechanical, biomedical, or materials engineering preferred)
- 5+ years of industry experience required
- 1+ years of leadership experience required, people management experience preferred
- Deep understanding of sterilization and biocompatibility preferred
- Working knowledge of data collection, data analysis/evaluation, and scientific methodology
- Class III (preferred) or II medical device experience required
- 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.
Want to learn more about Penumbra? Visit Penumbra's website.
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