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Penumbra

Mechanical Design Engineer II (Manufacturing & Tooling – Medical Devices)

Roseville, CA$79k–$100kexternalmidAdded today

About this role

Design and develop manufacturing tooling, fixtures, and equipment for medical devices in a Roseville-based manufacturing engineering role. You'll solve production challenges, optimize processes, and collaborate cross-functionally to commercialize products while maintaining compliance with quality and regulatory standards.

What you'll do

  • Design and create technical drawings for equipment, fixtures, and tooling used in medical device manufacturing
  • Conduct root cause analysis on production issues and implement validated solutions to improve yield and efficiency
  • Develop specifications, select components, and coordinate supplier relationships for new manufacturing equipment
  • Perform equipment qualifications and monitor performance to identify continuous improvement opportunities
  • Train production staff on new processes, equipment operation, and documentation procedures
  • Manage project planning, scheduling, and coordination while ensuring compliance with QMS and FDA regulations

What they're looking for

  • Mechanical design and CAD proficiency
  • Problem-solving and root cause analysis
  • Fixture and tooling design
  • Microsoft Office (Word, Excel, PowerPoint, Access)
  • FDA regulations and quality management systems
  • Lean/Flow Manufacturing
  • Cross-functional communication
  • Project management and scheduling

Benefits

  • Competitive compensation package
  • Equity program eligibility
  • On-site work in medical device manufacturing environment
  • Professional development opportunities
  • Exposure to global product commercialization projects
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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.

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Likely interview questions

  • Describe your experience designing fixtures or tooling for production environments and how you ensured manufacturability.
  • Walk us through a time you conducted root cause analysis on a manufacturing problem—what was your approach and outcome?
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