Senior Quality Engineer, Medical Devices

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

Benefits offered by this job

Medical, dental, vision

401(k) with employer match

Parental leave

Paid vacation

Paid sick time

Job summary

Penumbra, Inc. in California seeks a Sr. Quality Engineer to plan, execute independent quality work and maintain manufacturing quality standards. You will support design control, QA activities, and communication with stakeholders to ensure compliance.

The role involves leading cross‑functional teams, participating in qualification activities for new and existing products, and assisting FDA inspections and CAPA processes. A 5+ year background in QA for medical devices is required.

Qualifications

• Bachelor’s degree in Engineering or related field with 5+ years of quality assurance experience.
• Experience in ISO and audits in a medical devices or regulated environment.
• Experience with design review, project management, and product development.

Responsibilities

• Participate in development and qualification activities for new and existing products.
• Lead project teams coordinating quality efforts to design, develop, and improve products.
• Maintain and track hardware PCBA issues and communicate with stakeholders.
• Perform design-control driven engineering work and validate measurement methods.
• Support developmental projects in quality assurance and CAPA management.
• Assist in training, FDA inspections, and development of SOPs.

Skills

Quality Assurance

Design Review

Project Management

Auditing

Medical Devices

PCBAs

Education

Bachelor’s degree in Engineering

Advanced degree

Job description

Penumbra, Inc. in California seeks a Sr. Quality Engineer to plan, execute independent quality work and maintain manufacturing quality standards. You will support design control, QA activities, and communication with stakeholders to ensure compliance.

The role involves leading cross‑functional teams, participating in qualification activities for new and existing products, and assisting FDA inspections and CAPA processes. A 5+ year background in QA for medical devices is required.