Quality Engineer II

Penumbra is a global healthcare company focused on innovative therapies, designing, developing, manufacturing, and marketing novel products to address challenging medical conditions in markets with significant unmet need.
Alameda, CA, USARoseville, CA, USA
$95,930 - $126,330
Mid-Level Software Engineer
In-Person
2+ years of experience
Healthcare

Description For Quality Engineer II

As a Quality Engineer II at Penumbra, you will be responsible for ensuring the quality of game-changing medical devices used to address some of the world's toughest disease states. You'll work on highly technical problems throughout all stages of the process, from concept to commercialization and continuous improvements. Your role will involve working on production lines manufacturing high-performing catheter products, providing input in the design control process, developing and launching new products, and driving process improvements. You'll also lead strategic plans for biocompatibility and sterilization for upcoming products and determine root causes of in-process quality assurance issues. This position requires adherence to the company's Quality Management System and global quality regulations. You'll need 2+ years of experience in a manufacturing or laboratory environment (medical device experience preferred), a Bachelor's or Master's degree in an engineering or scientific discipline, and a passion for working on products that have a meaningful impact on people's lives. The role offers the opportunity to be part of a team revolutionizing the treatment of some of the world's most devastating diseases, along with a generous benefits package including medical, dental, vision insurance, 401(k) with employer match, and paid time off.

Last updated 4 months ago

Responsibilities For Quality Engineer II

  • Experience on production lines manufacturing high performing catheter products
  • Provide valuable input in the design control process and help in developing and launching new products
  • Independently provide knowledge of Penumbra Quality Management System
  • Identify and drive areas of opportunity for process improvement, yield improvement, and cycle time reduction
  • Lead strategic plans for biocompatibility and sterilization for upcoming products
  • Determine root-cause of in-process quality assurance issues
  • Adhere to the Company's Quality Management System (QMS) and quality regulations
  • Ensure other members of the department follow the QMS, regulations, standards and procedures

Requirements For Quality Engineer II

  • 2+ years experience in a manufacturing or laboratory environment required; medical device experience preferred
  • A Bachelor's or Master's degree in an engineering or scientific discipline required
  • Clear and concise written and oral communication skills preferred
  • A strong drive to work on products that have a meaningful impact on peoples' lives
  • Proven ability to thrive in a fast-paced work environment where navigating grey areas is a welcomed challenge
  • A passion for working in collaborative and dynamic teams with a feedback-rich culture

Benefits For Quality Engineer II

401k
Dental Insurance
Medical Insurance
Parental Leave
Vision Insurance
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • AD&D insurance
  • Short and long-term disability insurance
  • 401(k) with employer match
  • Employee stock purchase plan
  • Paid parental leave
  • Eleven paid company holidays per year
  • Minimum of fifteen days of accrued vacation per year, increasing with tenure
  • Paid sick time

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