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Quality Engineer I

General Summary

As a Quality Engineer I, 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! Unlike quality engineering roles in other companies, 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

•Provide valuable input in the design control process and help in developing and launching new products

•Lead strategic plans for biocompatibility and sterilization for upcoming 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

•Determine root-cause of in-process quality assurance issues

•Experience on production lines manufacturing high performing products

•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

•1+ years of experience in a manufacturing or laboratory environment strongly preferred

•Proven ability to thrive in a fast-paced work environment where navigating grey areas is a welcomed challenge preferred

•A Bachelor’s or Master's degree in an engineering or scientific discipline required

•Clear and concise written and oral communication skills required

•A passion for working in collaborative and dynamic teams with feedback-rich culture preferred

Working Conditions

•General office environment. Business travel from 0% - 10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.


Location and Pay 

•Alameda, CA 

•$80,000 to $105,000       

•Individual compensation will vary over time-based on factors such as performance, skill level, competencies, work location and shift.




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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Average salary estimate

$92500 / YEARLY (est.)
min
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$80000K
$105000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Quality Engineer I, Penumbra

At Penumbra, Inc., as a Quality Engineer I, you'll jump into the exciting world of medical device innovation aimed at tackling formidable health challenges. Nestled in the vibrant city of Alameda, CA, this role is not just another job; it's an opportunity to make a real difference in the safety and efficacy of life-changing products. Your expertise will shine as you navigate through complex quality control issues, ensuring that each product meets our high standards of excellence. You'll play a vital role in everything from the design phase to the continued improvement of our medical devices. If you have a knack for creative problem-solving and enjoy working in a dynamic, collaborative environment, you’ll find yourself right at home here. Your contributions will help shape the launch of new products and optimize current processes, all while adhering to our comprehensive Quality Management System. You'll also share your insights on biocompatibility and sterilization, fueling innovations that save lives. With an annual salary ranging from $80,000 to $105,000 and an extensive benefits package, Penumbra ensures a supportive workplace where your growth is valued and rewarded. Join us in revolutionizing healthcare and be part of a team that pushes boundaries every day!

Frequently Asked Questions (FAQs) for Quality Engineer I Role at Penumbra
What responsibilities are associated with the Quality Engineer I position at Penumbra?

As a Quality Engineer I at Penumbra, your primary responsibilities will include providing input in the design control process, leading strategic plans for biocompatibility and sterilization, and sustaining manufacturing operations. You’ll also identify areas for process improvement, determine root causes of quality assurance issues, and ensure compliance with our Quality Management System.

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What qualifications are required for the Quality Engineer I role at Penumbra?

To qualify for the Quality Engineer I position at Penumbra, you should possess at least a Bachelor’s or Master's degree in an engineering or scientific discipline, along with a minimum of one year of experience in a manufacturing or laboratory setting. Strong communication skills and a passion for teamwork are also essential to thrive in our innovative environment.

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How does Penumbra's Quality Engineer I position differ from similar roles in other companies?

Unlike many other companies, Penumbra's Quality Engineer I role emphasizes tackling highly technical problems in the medical device sector, empowering you to make significant contributions to patient safety. You'll be involved in every phase of product development, making it a unique opportunity to apply your skills in an impactful way.

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What is the work environment like for the Quality Engineer I at Penumbra?

The work environment for the Quality Engineer I at Penumbra is collaborative and dynamic, located in a general office setting with a small amount of business travel. You’ll have the chance to engage with various teams and enjoy a feedback-rich culture that promotes learning and professional growth.

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What can candidates expect in terms of salary and benefits for the Quality Engineer I role at Penumbra?

For the Quality Engineer I position at Penumbra, you can expect a competitive salary ranging from $80,000 to $105,000, with individual compensation based on factors such as performance and experience. In addition, Penumbra offers a generous benefits package, including medical, dental, vision, and a 401(k) plan with employer matching.

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Common Interview Questions for Quality Engineer I
How do you approach quality assurance within the product lifecycle?

In the context of the Quality Engineer I role at Penumbra, focus on the importance of active engagement during each phase of the product lifecycle. Discuss strategies like conducting thorough design reviews, risk assessments, and implementing controls to ensure product safety and effectiveness.

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Can you describe a time you identified a quality issue and how you resolved it?

Share a specific example that highlights your problem-solving skills. Detail the steps you took to identify the root cause, the analytic methods used, and the solutions you implemented. This shows your capability to handle challenges effectively in the Quality Engineer I position.

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What is your experience with regulatory requirements in the medical device industry?

Discuss any prior experience you have with quality regulations, such as ISO standards or FDA requirements. Highlight how this knowledge will help you in the quality management systems at Penumbra and ensuring compliance across processes.

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How do you prioritize tasks when managing multiple projects?

Explain your approach to prioritization techniques, such as using deadlines, impact assessments, and database analytics to manage and execute projects efficiently. This is crucial for the Quality Engineer I role, where managing quality across products is key.

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What methods do you use to analyze data for quality testing?

Detail your familiarity with statistical methods, quality control charts, or software tools you’ve utilized to assess data related to quality testing. Show how this experience aligns with the expectations for the Quality Engineer I position.

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How do you ensure communication and collaboration within cross-functional teams?

Highlight your communication skills and provide examples of how you foster collaboration in diverse teams. In the role of Quality Engineer I, effective collaboration will be essential to meet project goals and share insights.

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What do you consider your biggest achievement in quality engineering?

Select a specific achievement that demonstrates your skills and impact in quality engineering. Tailor your story to illustrate how it could be relevant to Penumbra's mission and the responsibilities of the Quality Engineer I role.

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How do you stay updated with the latest technologies and trends in quality engineering?

Discuss your methods for continuing education, such as attending conferences, participating in webinars, or joining professional organizations. This shows your commitment to staying at the forefront of the quality engineering field as a Quality Engineer I.

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Describe how you would handle a disagreement within your team about a quality process.

Emphasize your problem-solving capabilities by describing methods for conflict resolution, such as facilitating open discussions, compromising when necessary, and aligning on common goals—an essential skill for the collaborative culture at Penumbra.

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What excites you most about working at Penumbra as a Quality Engineer I?

Share your passion for contributing to innovative healthcare solutions and how Penumbra’s mission to address significant health challenges aligns with your professional values and aspirations. This passion is crucial for thriving in a role dedicated to enhancing product quality.

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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 ...

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March 28, 2025

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