Penumbra
Quality Engineer II - Catheters
Roseville, CAexternalmidAdded today
About this role
Quality Engineer II role focused on catheter product development and manufacturing quality assurance. Responsible for implementing quality systems, conducting testing, and supporting regulatory compliance for medical device products.
What you'll do
- Develop and execute quality test plans and protocols for catheter products
- Support manufacturing process validation and continuous improvement initiatives
- Conduct failure analysis and implement corrective actions
- Ensure compliance with regulatory requirements and quality standards
- Collaborate with cross-functional teams on product development and troubleshooting
- Document and maintain quality records and technical reports
What they're looking for
- Quality assurance and testing methodologies
- Medical device regulations (FDA, ISO standards)
- Statistical analysis and data interpretation
- Problem-solving and root cause analysis
- Technical documentation and report writing
- Manufacturing process knowledge
- Cross-functional collaboration
- Attention to detail
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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 with medical device quality systems and regulatory compliance.
- How have you approached failure analysis and implementing corrective actions in previous roles?