General Summary
As a Senior Quality Engineer, you will support manufacturing operations and production lines for a range of medical devices. You will apply strong analytical and problem-solving skills to maintain process control, strengthen inspection and monitoring systems, and contribute to yield and quality improvements from early commercial ramp through mature production. This role requires strong independent judgment, technical depth, and the ability to evaluate, adapt, and apply standard engineering and quality practices to complex manufacturing challenges. You will plan and conduct work with independence, devise new approaches to problems, and contribute to the development, application, and continuous improvement of quality standards within Operations. Working 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 key quality partner to Production, Manufacturing Engineering, and Industrial Engineering
•Lead complex 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
•Champion and 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 digital 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
•Conduct and 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)
•5+ years of experience in Quality Engineering or Manufacturing Engineering within the medical device industry
•Experience supporting manufacturing operations, process development, or NPI
•Working knowledge of FDA QSR and ISO 13485 in a manufacturing environment
•Strong data analysis, problem solving, and decision making skills
Preferred Experience:
•CQE certification or related training
•Experience supporting high volume manufacturing and early commercial yield ramp
•Background in inspection systems, destructive testing, and statistical sampling methods
•Experience managing projects or coordinating cross functional project activities
•Experience with Measurement System Analysis (MSA) and Six Sigma Black Belt projects
•Experience collaborating with Production, Industrial Engineering, and Equipment Engineering teams
•Versatility, flexibility, and willingness to work within a dynamic environment
Working Conditions:
•General office, laboratory, and cleanroom environments.
•Business travel from 0% - 10%.
•Potential exposure to blood-borne pathogens.
•Requires some lifting and moving of up to 25 pounds.
•Must be able to move between buildings and floors.
•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
•Must be able to read, prepare emails, and produce documents and spreadsheets.
•Must be able to move within the office and access file cabinets or supplies, as needed.
•Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Location and Pay:
•Alameda, CA
•$125,000 to $175,000
Skills Required
- Bachelor's degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related discipline)
- 5+ years of experience in Quality Engineering or Manufacturing Engineering within the medical device industry
- Experience supporting manufacturing operations, process development, or NPI
- Working knowledge of FDA QSR and ISO 13485 in a manufacturing environment
- Strong data analysis, problem solving, and decision making skills
- Experience applying Lean and Six Sigma methodologies
- Experience leading root cause investigations using structured problem solving tools (5 Why, Fishbone, DOE, regression analysis)
- CQE certification or related training
- Experience supporting high volume manufacturing and early commercial yield ramp
- Background in inspection systems, destructive testing, and statistical sampling methods
- Experience managing projects or coordinating cross functional project activities
- Experience with Measurement System Analysis (MSA) and Six Sigma Black Belt projects
- Experience collaborating with Production, Industrial Engineering, and Equipment Engineering teams
- Versatility, flexibility, and willingness to work within a dynamic environment
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.
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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.
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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.
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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.
Penumbra Insights
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.
