Penumbra
Quality Engineer III - Catheters
About this role
Quality Engineer III responsible for developing and implementing quality system elements for catheter products in a medical device environment. The role involves leading product qualification activities, designing quality control processes, conducting failure analyses, and ensuring regulatory compliance while mentoring junior engineers.
What you'll do
- Lead or collaborate on product development and qualification activities for new and existing catheters
- Design and implement quality control sampling systems, statistical techniques, and inspection procedures
- Perform failure analyses, defect investigations, and recommend specification revisions
- Develop testing and inspection methodologies and documentation
- Partner with engineering, customers, and suppliers to resolve quality issues
- Facilitate internal audits and provide guidance to junior Quality Engineers
What they're looking for
- Quality system regulations (QSR) and ISO standards knowledge
- Failure analysis and root cause investigation
- Statistical process control and sampling design
- Medical device quality systems experience
- Technical writing and documentation
- Microsoft Office (Word, Excel, PowerPoint)
- Leadership and mentoring
- Regulatory compliance and auditing
Benefits
- Competitive compensation package
- Equity program when applicable
- Work in modern office, laboratory, and cleanroom environments
- Opportunity for leadership development
- Minimal travel requirements (0-10%)
- Collaborative engineering culture
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Penumbra
Penumbra develops innovative medical devices supported by embedded firmware and manufacturing excellence. The company is hiring mechanical design engineers, manufacturing engineers, R&D engineers, and forward-deployed engineers to optimize production processes, advance product development, and deploy AI-driven solutions.
View all jobs at PenumbraLikely interview questions
- Describe your experience developing and implementing quality control procedures in a medical device or manufacturing environment.
- Walk us through how you would approach a failure analysis for a catheter product that failed customer acceptance testing.