Penumbra Jobs

Quality Engineer III

Penumbra

Quality Engineer III

Reposted Yesterday

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Alameda, CA, USA

In-Office

109K-152K Annually

Mid level

Healthtech

The Role

The Quality Engineer III will support manufacturing of medical devices through inspections, failure analyses, continuous improvement efforts, and documentation development while providing guidance to junior engineers.

Summary Generated by Built In

General Summary

As a Quality Engineer III, you will support manufacturing operations and production lines for a range of medical devices. This role requires you to tackle complex, ambiguous quality challenges in our manufacturing processes with a high degree of autonomy, applying advanced problem solving and thoughtful decision-making from early commercial ramp through mature production. Your work will directly impact patient safety and product performance, while influencing cross functional decisions, leading investigations, proactively identifying risk, and helping shape robust, scalable quality systems that support both innovation and compliance. You will partner closely with Manufacturing Engineering, Production, and Industrial Engineering to ensure quality is built into every stage of the manufacturing process.

Specific Duties and Responsibilities

• Provide Quality Engineering support for assigned products and production lines

• Act as a quality partner to Production, Manufacturing Engineering, and Industrial Engineering

• Lead root cause investigations using structured problem solving tools (5 Why, Fishbone, DOE, regression analysis)

• Support monitoring of manufacturing quality performance, including yield, scrap, and process capability

• Improve inspection strategies, including in process and final inspection, destructive testing, sampling plans, and acceptance criteria

• Lead continuous improvement of inspection systems, test methods, process monitoring, and other quality tools

• Apply Lean and Six Sigma methodologies to reduce waste and improve process capability

• Execute quality system activities within Operations, including NCRs, MRB, CAPAs, control chart investigations, and effectiveness verification

• Maintain pFMEAs, ensuring risks are mitigated through appropriate controls and monitoring

• Support early commercial ramp-up, material or process changes, and site transfers

Position Qualifications

Minimum education and experience:

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related discipline preferred)

• 3+ years of experience in Quality Engineering or Manufacturing Engineering within the medical device industry

• Experience supporting manufacturing operations, process development, or NPI

• Strong problem solving, data analysis, and decision making skills

• Excellent verbal, written, and interpersonal communication skills

Preferred Experience:

• Familiarity with QSR, ISO, and other applicable regulations and laws

• Experience supporting high volume manufacturing and early commercial yield ramp

• Experience leading projects or coordinating cross functional project activities

• Background in inspection systems, destructive testing, and statistical sampling methodsVersatility, flexibility, and willingness to work within a dynamic environment

Working Conditions

• General office, laboratory, and cleanroom environments

• 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 includes the ability to read, close vision, distance vision, color vision, peripheral

vision, and depth perception.

• Alameda, CA

• Starting Base Salary is $109,000/year to $152,000/year

The above statements are intended to describe the general nature and level of work being

performed by people assigned to this classification. They are not intended to be construed as an

exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

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, 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.

Skills Required

Associate's or Bachelor's degree in Engineering, Life Science, or related field
3+ years of quality engineering or relevant experience in medical devices
Familiarity with QSR, ISO, and applicable regulations
Excellent verbal, written, and interpersonal communication skills
Leadership skills

Penumbra Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Penumbra and has not been reviewed or approved by Penumbra.

Healthcare Strength — Company materials describe comprehensive medical, dental, and vision coverage with immediate eligibility, alongside life and disability insurance. Feedback suggests health coverage quality is a standout element of the package.
Parental & Family Support — Company sources indicate fully paid parental leave and on-site support for nursing parents in key locations. Feedback suggests family support policies compare favorably within med‑tech employers.
Leave & Time Off Breadth — Company postings outline paid holidays, sick leave, and vacation that increases with tenure. Feedback suggests time‑off provisions are broadly competitive when weighing total package value.

Learn more about Penumbra's Compensation & Benefits →

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The Company

HQ: Alameda, CA

1,950 Employees

Year Founded: 2004

What We Do

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.