General Summary

As a Principal Quality Engineer, you will serve as a technical leader driving quality improvement across Operations. You will apply deep analytical expertise to strengthen process capability, optimize inspection and monitoring systems, and elevate quality performance through structured continuous improvement methodologies.

This role requires structured Quality Engineering approaches, strong engineering analysis and methodologies, statistical experience, and the ability to architect scalable Quality Engineering systems that prevent defects, reduce variation, and enhance long‑term manufacturing robustness. You will influence quality strategy, develop new approaches to systemic quality challenges, and champion a culture of operational excellence across the organization.

Working cross‑functionally with Manufacturing Engineering, Industrial Engineering, Operations Leadership, and R&D, you will ensure that quality is proactively designed into processes, risks are systematically mitigated, and improvement opportunities are identified and executed with rigor.

Specific Duties and Responsibilities

Lead cross-functional continuous improvement initiatives focused on reducing Cost of Poor Quality, improving process capability, and strengthening Critical to Quality performance across manufacturing operations.

Identify, quantify, and prioritize systemic quality improvement opportunities using data‑driven methods, advanced analytics, and structured problem‑solving frameworks.

Own complex NCRs and CAPAs, and participate in NCR boards
Develop and deploy CTQ flowdowns, ensuring alignment between product requirements, process controls, and inspection strategies.

Architect and optimize quality monitoring systems, including predictive analytics, statistical process control, and automated data visualization tools.

Lead high‑complexity problem-solving efforts using advanced statistical and scientific methods (DOE, regression modeling, multivariate analysis, reliability modeling).

Drive continuous improvement of inspection systems, test methods, and measurement capability, including automation, sampling optimization, and risk‑based acceptance strategies.

Champion Lean, Six Sigma, and operational excellence methodologies, setting direction for waste reduction, variation control, and process robustness.

Influence long‑term quality strategy, including technology adoption, digital quality transformation, and advanced analytics integration.

Train and mentor Quality Engineers, elevating technical capability and fostering a culture of scientific thinking and continuous improvement.

Position Qualifications

Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related discipline preferred); advanced degree strongly preferred.

7+ years of experience in Quality Engineering, Continuous Improvement, or Manufacturing Engineering within the medical device industry.

Experience in Lean and Six Sigma methodologies, leading large‑scale continuous improvement, Cost of Quality reduction, or CTQ deployment programs.

Expert‑level understanding of FDA QSR and ISO 13485 in a manufacturing context.

Proven ability to lead cross‑functional teams through complex technical challenges and strategic quality initiatives.

Advanced data analysis, statistical modeling, and decision‑making skills.

Preferred Experience

ASQ CQE, CSSBB, or equivalent advanced quality certification.

Deep expertise in inspection technologies, destructive testing, sampling theory, and measurement system analysis.

Experience implementing automation, digital quality systems, or advanced analytics platforms.

Strong collaboration with Manufacturing Engineering, Industrial Engineering, Equipment Engineering, and R&D.

Ability to thrive in a dynamic, fast‑paced environment while influencing long‑term quality strategy.

Location: Roseville, CA

Annual Base Salary Range: $135,000 to $175,000

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Working Conditions:

General office, laboratory, and cleanroom environments

Business travel from 0% – 10%

Potential exposure to bloodborne pathogens

Requires lifting and moving up to 25 pounds

Must be able to move between buildings and floors

Must be able to remain stationary and use standard office equipment for extended periods

Must be able to read, prepare emails, and produce documents and spreadsheets

Must be able to move within the office and access files or supplies as needed

Must be able to communicate and exchange accurate information with employees at all levels

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 seePenumbra's AAP Policy Statement.

About the company

Penumbra develops and sells medical devices for neurovascular and peripheral vascular conditions. Its products assist doctors in treating stroke and other vascular diseases by delivering—through systems like the Penumbra System and Indigo System—catheters, coils, and evacuation devices that are placed inside blood vessels. The company differentiates itself with a broad, integrated portfolio and a global sales network across Europe and the Americas, emphasizing engineering and clinical performance. Its goal is to improve patient outcomes and sustain growth by investing in ongoing research and development to expand its capabilities.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

Alameda, California

Founded

2004

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Simplify's Take

What believers are saying

Q2 2026 revenue reached $390.0 million, up 14.9%, with 67.9% gross margin.
September 9, 2026 Link launch expands Lightning Bolt workflows for resistant clot.
Magnendo's $18 million round, led by Penumbra, extends its stroke robotics ecosystem.

What critics are saying

June 3, 2026 RED 68 recall flags manufacturing defects and franchise reliability.
Incuvate sued Penumbra on August 19, 2026 over THUNDERBOLT patents; injunction risk.
Boston Scientific's acquisition still requires approvals; any 2026 slip derails employee retention and valuation.

What makes Penumbra Inc unique

Penumbra's CAVT platform pairs computer control with thrombectomy; THUNDERBOLT cleared FDA in 2026.
Broad neurovascular and peripheral portfolios sell into over 100 countries.
Deep physician evidence engine adds leaders like Donald Frei and published stroke studies.

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Benefits

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
401(k) Company Match
Paid Parental Leave
Paid Vacation
Paid Sick Leave
Paid Holidays

Growth & Insights and Company News

Headcount

6 month growth

1 year growth

2 year growth

Business Insider

Oct 2nd, 2026

RBC Capital keeps their Hold rating on Penumbra (PEN).

RBC Capital keeps their Hold rating on Penumbra (PEN). Oct. 2, 2026, 09:47 PM In a report released on October 1, Kendall Au from RBC Capital maintained a Hold rating on Penumbra, with a price target of $374.00. The company's shares closed yesterday at $318.00. According to TipRanks, Au is an analyst with an average return of -3.6% and a 22.22% success rate. Au covers the Healthcare sector, focusing on stocks such as Becton Dickinson, GE Healthcare Technologies Inc, and Boston Scientific. Penumbra has an analyst consensus of Hold, with a price target consensus of $358.40. Based on Penumbra's latest earnings release for the quarter ending June 30, the company reported a quarterly revenue of $390.05 million and a net profit of $34.81 million. In comparison, last year the company earned a revenue of $339.46 million and had a net profit of $45.27 million Read More on PEN:

Penumbra, Inc.

Sep 9th, 2026

Penumbra launches Link, expanding vascular thrombectomy options for physicians.

Penumbra launches Link, expanding vascular thrombectomy options for physicians. September 9, 2026 Penumbra recently launched the Link(TM) clot capture device designed to support the removal of arterial thrombus when used in conjunction with Lightning Bolt(R) technology. Link is designed to lock and hold clot, connecting to the power of computer assisted vacuum thrombectomy (CAVT(R) to secure and maximize clot extraction. "Link expands the toolkit available to physicians by providing an additional mechanical clot engagement option that can help address resistant thrombus while maintaining aspiration with CAVT," said James F. Benenati, MD, FSIR, chief medical officer at Penumbra. "By offering clinicians greater flexibility in challenging cases, it has the potential to improve procedural efficiency and support more effective patient care." Deployed into thrombus, Link engages and mobilizes organized clot while aspiration facilitates clot ingestion into the aspiration catheter. Designed to complement existing Lightning Bolt workflows, Link can be incorporated when additional mechanical clot engagement is desired, without requiring a fundamentally different procedural approach. Early physician experience has highlighted Link's ability to work synergistically with Lightning Bolt technology. "Link appeared to provide a secure hold on the embolus, allowing Bolt to more effectively aspirate the residual thrombus," said Thomas Heafner, MD, after using Link with Bolt 7. "Combining Link with Lightning Bolt resulted in rapid and effective clot clearance." "Link represents an important advancement in our CAVT portfolio, providing an additional option for engaging and removing challenging blood clots," said Shruthi Narayan, president of Penumbra. "Link was designed to bring a new dimension to thrombectomy by combining secure clot engagement with the power of modulated aspiration, offering clinicians an additional therapeutic option for some of the most challenging cases. This launch reflects our continued commitment to developing technologies that advance vascular care and improve patient outcomes." Designed to Secure Clot and Maximize Extraction LINK is designed to lock and hold clot while leveraging the power of CAVT to support clot removal. Its unique architecture is engineered to minimize vessel wall engagement and support atraumatic clot extraction. Important Safety Information Additional information about Penumbra's products can be located on Penumbra's website at https://www.penumbrainc.com/products/peripheral-thrombectomy-cavt/. The clinical results presented herein are for informational purposes only and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors. Caution: Federal (USA) law restrictions these devices to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use (IFU) for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. For the complete Penumbra IFU Risk Summary Statements, visit: peninc.info/risk. Please contact your local Penumbra representative for more information.

GlobeNewswire

Aug 25th, 2026

Incuvate files patent infringement lawsuit against Penumbra.

Incuvate files patent infringement lawsuit against Penumbra. Complaint alleges Penumbra's THUNDERBOLT(TM) system infringes five Incuvate patents covering blood-clot detection technology. August 25, 2026 15:28 ET | Source: Incuvate LLC IRVINE, Calif., Aug. 25, 2026 (GLOBE NEWSWIRE) - Incuvate, LLC today announced that it has filed a patent-infringement lawsuit against Penumbra, Inc. in the U.S. District Court for the Northern District of California. The lawsuit, filed August 19, 2026, alleges that Penumbra's recently launched THUNDERBOLT(TM) Neurovascular Thrombectomy System and related components infringe five Incuvate patents directed to real-time aspiration monitoring technology used in catheter-based thrombectomy procedures. Incuvate's patents cover technology that uses pressure sensors, microprocessors, and pre-set pressure thresholds or differentials to provide real-time visual and audible feedback during aspiration procedures. Incuvate alleges that this technology helps distinguish between clot engagement and blood flow and provides clinicians with valuable information during thrombectomy procedures. The complaint identifies Penumbra's THUNDERBOLT system, Penumbra ENGINE vacuum source, THUNDERBOLT tubing and module, and associated RED Reperfusion Catheters as accused products. Incuvate alleges that these products use patented technology to detect flow conditions, including the presence of clot, and provide users with feedback regarding flow status. Through this lawsuit, Incuvate seeks to hold Penumbra accountable for what Incuvate alleges is Penumbra's unauthorized and willful infringement of the technologies embodied in the asserted patents. Incuvate is seeking damages, injunctive relief, and other remedies described in the complaint. A copy of the complaint is available through PACER Monitor in Incuvate, LLC v. Penumbra, Inc., Case No. 4:26-cv-08658. About Incuvate Incuvate works with medical device entrepreneurs to develop early-stage concepts into innovative products and leads them to market via new companies it finances, builds, and manages. Learn more at incuvatellc.com Media Contact Lance Capel Director of Strategy & External Relations [email protected]

Penumbra, Inc.

Aug 10th, 2026

Dr. Donald Frei joins Penumbra as Associate Chief Medical Officer of Neuro.

Dr. Donald Frei joins Penumbra as Associate Chief Medical Officer of Neuro. August 10, 2026 Penumbra announced today that Donald Frei, MD, FSNIS, FACR, will serve as Associate Chief Medical Officer of Neuro. A nationally recognized neurointerventional surgeon, Dr. Frei brings clinical and research expertise in stroke and neurovascular care to Penumbra's clinical leadership team. Reporting to James Benenati, MD, FSIR, Chief Medical Officer of Penumbra, Dr. Frei will help guide Penumbra's neurovascular clinical strategy, support evidence development, and collaborate with physicians worldwide to advance patient care. "Dr. Frei has dedicated his career to advancing neurovascular care, from pioneering faster stroke recanalization protocols to helping establish the clinical evidence behind therapies that improve patient outcomes," said Dr. Benenati. "His deep clinical expertise, commitment to innovation, and passion for patient care will be invaluable as we continue to expand the impact of our neurovascular technologies around the world." Throughout his career, Dr. Frei has authored more than 200 peer-reviewed publications and contributed to the advancement of neurovascular therapies through extensive clinical research and evidence generation. Recently, Dr. Frei was the co-principal investigator of the THUNDER Study, which demonstrated that Penumbra's CAVT(TM)(Computer Assisted Vacuum Thrombectomy) platform with THUNDERBOLT technology is safe and effective, paving the way for FDA clearance and CE Mark. Dr. Frei was also instrumental in launching the Get Ahead of Stroke(R) campaign to improve stroke triage and expand access to life-saving neuroendovascular care. "With the recent launch of CAVT with THUNDERBOLT, the neurovascular space is prime for transformation," said Dr. Frei. "I look forward to this opportunity to help advance innovation, generate evidence, deepen trust and closer collaboration with our medical and professional societies, and improve access to care so more patients are able to benefit from the latest technology." Dr. Frei is a leading board-certified neurointerventional surgeon and is a past president of the Society of NeuroInterventional Surgery. He earned his medical degree from the University of Cincinnati College of Medicine and completed his residency training in diagnostic radiology at Tulane University Medical Center. He subsequently completed fellowship training in neuroradiology and endovascular surgical neuroradiology at Washington University's Mallinckrodt Institute of Radiology. He has been recognized as a Fellow of the Society of NeuroInterventional Surgery (FSNIS) and a Fellow of the American College of Radiology (FACR).

Yahoo Finance

Jul 30th, 2026

Penumbra reports $390M Q2 revenue, up 14.9% ahead of Boston Scientific acquisition

Penumbra reported second quarter 2026 revenue of $390.0 million, up 14.9% year-over-year. The thrombectomy company's global thrombectomy revenue reached $259.0 million, increasing 12.5%, whilst embolization and access revenue grew 20.0% to $131.1 million. Gross profit margin improved to 67.9%, up 1.9 percentage points from the prior year. Operating income was $41.0 million, with net income of $34.8 million. Total operating expenses stood at $223.9 million, including $6.9 million in acquisition-related costs. Due to Boston Scientific's pending acquisition of Penumbra, the company will not provide full-year 2026 guidance or host a conference call to discuss results. Penumbra operates in over 100 countries, focusing on thrombectomy technologies for conditions including ischaemic stroke and pulmonary embolism.

Penumbra Inc

Principal Quality Engineer

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