Full-Time

Manufacturing Engineer I

Penumbra Inc

Penumbra Inc

1,001-5,000 employees

Develops, manufactures, and markets medical therapies for unmet needs

Hardware

$75,780 - $100,742

Generous benefits package

Junior, Mid, Senior

Alameda, CA, USA

Requirements
  • BS degree in Mechanical, Biomedical, Chemical, or Materials Engineering, or a related discipline
  • Medical device experience
  • Proven knowledge of FDA regulations, lean manufacturing, and/or materials and manufacturing processes
Responsibilities
  • Solve complex problems and implement innovative solutions
  • Execute detailed root cause analysis and recommend vetted solutions
  • Communicate and explain problems and solutions cross-functionally and inter-departmentally
  • Support production needs
  • Create and maintain product and process documentation
  • Monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield
  • Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line
  • Test processes, equipment, raw materials, and product
  • Perform process validations
  • Author protocols to execute tests and write reports and make conclusions and/or recommendations based on test results
  • Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project
  • Develop specifications of a product, process, or piece of equipment
  • Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience
  • Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans
  • Participate in project planning and scheduling
  • Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation
  • Comply with quality system regulations, standards and procedures
  • Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
  • Ensure other members of the department follow the QMS, regulations, standards and procedures
  • Perform other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects

Penumbra, Inc. is a global healthcare company that stands out for its commitment to addressing unmet medical needs through the design, development, and marketing of novel products, such as the Penumbra System for the treatment of acute ischemic stroke. The company's culture fosters continuous learning and growth, with a strong emphasis on the value of every team member's ideas. Recognized as one of the fastest-growing companies by Fortune in 2019, Penumbra's industry leadership is evident in its direct sales organization that serves major markets including the United States, Europe, Canada, and Australia.

Company Stage

IPO

Total Funding

$3.4M

Headquarters

Alameda, California

Founded

2004

Growth & Insights
Headcount

6 month growth

5%

1 year growth

14%

2 year growth

22%
INACTIVE