Skip to main content

Penumbra

Development Quality Engineer I

Alameda, CA$80k–$105kexternalentryAdded today

About this role

A quality engineering role supporting the development and compliance of medical device products. You'll design testing methodologies, conduct failure analyses, and ensure adherence to regulatory standards like QSR and ISO to bring safe, compliant products to market.

What you'll do

  • Participate in product development and qualification activities for new and existing medical devices
  • Develop testing, inspection methodology, and documentation aligned with product requirements
  • Design and implement quality sampling systems using statistical analysis
  • Perform failure analyses and defect investigations to identify root causes
  • Specify inspection and testing equipment; recommend process improvements
  • Interface with internal teams, customers, and suppliers on quality-related issues

What they're looking for

  • Quality system regulations (QSR, ISO standards)
  • Statistical analysis and sampling design
  • Testing and inspection methodology development
  • Failure analysis and root cause investigation
  • Design control and design documentation
  • Microsoft Office (Word, Excel, PowerPoint)
  • Technical writing and documentation
  • Cross-functional communication

Benefits

  • Competitive compensation package
  • Equity program (when applicable)
  • Medical device industry experience
  • Exposure to product development lifecycle
  • Collaborative team environment
Apply with Autofill

Opens the application — the Jobs AI extension fills it for you. Set up autofill

Opens the official application on the employer’s site. No login required.

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 Penumbra

Likely interview questions

  • Describe your experience with QSR and ISO standards—which regulations have you worked with in detail?
  • Walk us through a failure analysis you conducted; how did you determine root cause and implement corrective actions?
Unlock all 7 questions free — and practice them live →