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Quality Engineer II

California, United States (On-site)

Quality Engineer II

1 Month ago • 2 Years + • Manufacturing

About the job

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Job Description

As a Quality Engineer, you will be responsible for ensuring the quality of Penumbra's game-changing medical devices used to treat a variety of diseases. You will work on a variety of tasks, including providing input on the design control process, developing new products, identifying areas for process improvement, and ensuring compliance with quality regulations. You will also be responsible for leading strategic plans for biocompatibility and sterilization. This role requires a strong understanding of the medical device industry and a passion for quality. You will be a key part of a team that is revolutionizing the treatment of some of the world's most devastating diseases.

Must have:

2+ years experience in manufacturing/lab
Medical device experience preferred
Strong drive to work on impactful products
Thrive in fast-paced environment
Bachelor's/Master's in engineering or science
Clear written and oral communication

Perks:

Collaborative teamwork environment
Learning and performance rewarded
Opportunity to revolutionize treatments
Medical, dental, vision, life, AD&D
Short and long-term disability insurance
401(k) with employer match
Employee stock purchase plan
Paid parental leave
11 paid company holidays
Minimum 15 days of accrued vacation
Paid sick time

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As a Quality Engineer, you will be charged with the quality behind Penumbra's game-changing medical devices used to address some of the world's toughest disease states! At Penumbra, we provide our quality engineers with highly technical problems to solve. Your efforts will directly impact the safety of patients around the world who use our products. You will apply your passion for creative problem solving throughout all stages of the process, from concept to commercialization and into continuous improvements.

What You'll Work On

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 as it pertains to sustaining manufacturing operations as well as dealing with supplier quality and developing new products
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) 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.

What You'll Bring

2+ years experience in a manufacturing or laboratory environment required; medical device experience 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 Bachelor’s or Master's degree in an engineering or scientific discipline required
Clear and concise written and oral communication skills preferred
A passion for working in collaborative and dynamic teams with a feedback-rich culture

What We Offer

•A collaborative teamwork environment where learning is constant, and performance is rewarded.

•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.

•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

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.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.

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