The Role
Lead a team of Quality Engineers to ensure manufacturing quality and process control for medical devices, employing Lean and Six Sigma methodologies for improvements.
Summary Generated by Built In
General Summary
In this role, you will lead a team of Quality Engineers supporting manufacturing operations and production lines for a portfolio of medical devices. You will be accountable for manufacturing quality performance, inspection strategy, yield improvement, and sustaining process control, from early commercial ramp through product maturity and site transfer.
Embedded within Technical Operations, this role partners closely with Manufacturing Engineering, Production, and Industrial Engineering to build quality into manufacturing processes from the start. From a quality-first perspective, you will ensure processes are capable, controlled, and appropriately de-risked through robust process controls, inspection strategies, and data-driven monitoring. Your work will directly influence product yield, productivity, and operational stability by preventing defects, detecting issues early, and ensuring consistent, compliant manufacturing performance.
Specific Duties and Responsibilities
•Lead Quality Engineering support for assigned product portfolios and production lines
•Serve as the primary quality partner to Production, Manufacturing Engineering, and Industrial Engineering
•Own manufacturing quality performance, including yield, scrap, productivity, and throughput-related quality losses
•Own and advance inspection strategies, including in-process and final inspection, destructive testing, sampling plans, and acceptance/reject criteria
•Drive continuous improvement of inspection systems, test methods, process monitoring, and digital quality tools
•Apply Lean and Six Sigma methodologies to improve yield, reduce waste, and enhance process capability
•Own execution of quality system activities within Operations, including NCRs, MRB, CAPAs, control chart investigations, and effectiveness verification
•Champion process-based risk management, including pFMEAs and defining CTQs
•Review and approve equipment-related quality activities, including equipment qualifications (IQ/OQ), equipment-related ECOs, non-standard maintenance activities, and equipment software validation, in partnership with Manufacturing Engineering
•Hire, develop, and manage Quality Engineers, including workload and FTE planning to support production priorities
*Indicates an essential function of the role
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
•1+ years of leadership experience required; people management experience preferred
•Previous manufacturing engineering, process development, or NPI experience preferred
•Working knowledge of FDA QSR and ISO 13485 in a manufacturing environment
•Prior people leadership experience or demonstrated readiness to manage and develop engineers
•Strong data analysis, problem-solving, and decision-making skills
Preferred Qualifications:
•Product Quality Engineering support for catheterization delivery systems and/or nitinol-based devices
•Experience supporting high-volume manufacturing and early commercial yield ramp
•Strong background in inspection systems, destructive testing, and statistical sampling methods
•Versatility, flexibility, and willingness to work within a dynamic environment
•Practical application of Lean and Six Sigma in manufacturing or quality environments
•Experience partnering closely with Production, Industrial Engineering, and Equipment Engineering teams
•CQE certification or training
•Experience with data systems (e.g. PowerBI or Tableau), statistical analysis, and design of experimentation
Working Conditions
•General office, laboratory, and cleanroom environments
•Business travel from 0% - 10%
•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: Alameda, CA
Starting Base Salary: $145,000 to $214,000
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, 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.
Top Skills
Fda Qsr
Iso 13485
Lean
Power BI
Six Sigma
Tableau
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The Company
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.
