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Development Quality Engineer IPenumbra, Inc. · Alameda, CA
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Penumbra, Inc.

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Development Quality Engineer I

🗓️ Posted 2026-08-27 Alameda, CA External Hybrid ICT
💰 Salary Not shared 📊 Market 6,500 CAD–8,500 CAD/mo

About the Company

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Members of the Penumbra team agree that this is where their work has meaning -- we are transforming the treatment of some of the world's most devastating conditions. Penumbra is where everyone's ideas matter, and where learning and growth are constant. No. 5 on the Greater Bay Area Manufacturers List, San Francisco Business Times, 2020 100 Fastest-Growing Companies, Fortune, 2019 Review our community guidelines for LinkedIn here: https://bit.ly/2Jmbw83. Medical Equipment Manufacturing Specialties: Neurointerventional devices, Stroke treatment, Vascular access, Thrombectomy systems, Interventional radiology, Medical device innovation

Responsibilities

  • ● General Summary
  • ● The Development Quality Engineer I works with product development teams to design and qualify new life-saving products. You will help develop and implement appropriate quality system elements to ensure the high-quality level of new and existing products and to ensure their compliance to all applicable regulations and standards. Help products safely and efficiently get to market by following standards and procedures to analyze situations and data from which conclusions can be readily obtained.
  • ● Specific Duties and Responsibilities
  • ● Participate in the product development and qualification activities for new and existing products
  • ● Participate in Product Development teams
  • ● Develop testing, inspection methodology, and documentation for new and existing products
  • ● Design and install quality sampling systems and procedures utilizing statistical analysis
  • ● Design or specify inspection and testing equipment to meet product requirements
  • ● Perform failure analyses and defect investigations
  • ● Analyze and apply design control standards
  • ● Recommend revision of specifications, procedures, and work instructions for device design and process improvement
  • ● Interface with other internal departments, customers, and suppliers on product and quality-related issues
  • ● Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
  • ● Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
  • ● Ensure other members of the department follow the QMS, regulations, standards, and procedures.
  • ● Perform other work-related duties as assigned
  • ● Indicates an essential function of the role
  • ● Position Qualifications
  • ● Minimum education and experience:
  • ● Associate's or Bachelor's degree in Engineering, a Life Science or a related field, plus quality engineering or relevant experience, preferably in a medical device environment, or equivalent combination of education and experience