Senior Quality Engineer, Medical Devices & Design Assurance

Penumbra, Inc.; San Francisco (CA); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

401(k)

Job summary

Penumbra, Inc. seeks a Sr. Quality Engineer to lead quality assurance efforts for medical devices in a regulated environment.

You will develop quality standards, monitor design control, and support FDA inspections while collaborating with cross-functional teams. The role emphasizes hands-on qualification activities, documenting findings, and driving corrective actions. A strong background in ISO practices, auditing, and project management is required, with 5+ years in medical devices or

Qualifications

• Bachelor’s degree in Engineering or Life Science with 5+ years of QA/regulatory experience.
• Advanced degree preferred.
• Experience auditing, design review, sterilization, project management and product development.
• Experience with Electronic devices and PCBAs.

Responsibilities

• Participate in development and qualification activities for new and existing products.
• Lead and participate in project teams coordinating quality efforts to design, develop, and improve products.
• Maintain and track hardware PCB issues and communicate with stakeholders.
• Perform engineering work including design verification and testing methods.
• Develop and validate measurement methods and monitor design control and regulatory standards.
• Analyze reports and returned products and recommend corrective/preventive actions.
• Perform statistical analysis and assign responsibility for non-conforming items.
• Participate in NCR or CAPA boards and assist in QSR training.
• Support FDA inspections and notified body audits and develop SOPs.
• Adhere to QMS and security/compliance principles; manage staff development.

Skills

Quality Assurance

Auditing

Project management

Design review

Statistical analysis

Education

Bachelor’s degree in Engineering or Life Science

Advanced degree preferred

Tools

PCB design/assembly knowledge

Job description

Penumbra, Inc. seeks a Sr. Quality Engineer to lead quality assurance efforts for medical devices in a regulated environment.

You will develop quality standards, monitor design control, and support FDA inspections while collaborating with cross-functional teams. The role emphasizes hands-on qualification activities, documenting findings, and driving corrective actions. A strong background in ISO practices, auditing, and project management is required, with 5+ years in medical devices or