Full-Time
Staff Quality Engineer
Design Quality, Pleasanton, CA
Calyxo
201-500 employees
Develops and markets kidney stone devices
Compensation Overview
$170k - $185k/yr
Pleasanton, CA, USA
Hybrid
Hybrid 4 days/week onsite, 1 day remote.
Bachelor's
 QA & Testing (1) |
|---|
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- Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Systems Engineering or a related technical field.
- Minimum 10 to 12+ years of experience in quality engineering within the medical device industry, with strong record of being a vital part of NPD launch.
- Strong knowledge, applications, and subject matter expertise of ISO 13485, ISO 14971, IEC 62304 and FDA 21 CFR Part 820.
- Excellent presentation skills and proactive leading mindset. Effective communication, collaborative attitude, and strong accountability mindset.
- Detailed understanding of design controls, risk management, and process validation in the context of medical device development from concept to feasibility to V&V to design transfer to launch.
- Experience with systems design verification and validation (V&V) activities, including support for development of test protocols and reports.
- Hands-on experience working with FMEA tools (design, software, user).
- Excellent problem-solving skills, with the ability to analyze complex technical issues and develop effective solutions. Proficient in statistical tools applications such as Minitab, Jump etc.
- Detail-oriented, with a commitment to producing high-quality work and maintaining rigorous documentation.
- Certifications such as ASQ CQE (Americal Society for Quality Certified Quality Engineer), ASQ CSQE (Certified Software Quality Engineer), Six Sigma Black Belt or similar are a plus.
- Work location: Pleasanton, CA.
- Travel: 5-10% domestic travel may be required.
- Full time employment.
- Must be able to lift 10-15 pounds and sit for up to 8 hours/day.
- Compliance with relevant county, state, and Federal rules regarding vaccinations.
- Hybrid 4 days/week onsite, 1 day remote.
- Ensure design controls for new product development and improvement project activities, including risk management, design V&V, product software validation, design reviews, tagging/tracing, non-product tools validation, test method validation, and design transfer are in compliance with Calyxo Quality System, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and relevant global regulations.
- Drive risk management activities per ISO 14971, including risk management plan, hazard analysis, FMEAs (design, software, user), risk-benefit analysis, and risk management report.
- Own and maintain design control documentation in compliance with ISO 13485 and 21 CFR Part 820.
- Collaborate with R&D, PMO, Regulatory Affairs, and Manufacturing to ensure robust design inputs, outputs, traceability and quality considerations are integrated into all phases of the product development lifecycle.
- Maintain accurate and up-to-date quality records, including test reports, validation reports, and risk management documentation. Prepare and present quality-related reports to management and project teams.
- Promote a structured software development process in compliance with IEC 62304, assuring that a state of control is maintained with robust software risk management.
- Support regulatory submissions (e.g., 510(k), CE Mark) by providing design assurance documentation and justifications.
- Support sterilization assessments as per ISO 11135 EO and ISO 11137 radiation requirements.
- Support biocompatibility assessments as per ISO 10993 requirements.
- Lead root cause investigations and corrective actions related to design-related issues.
- Mentor junior engineers and promote a culture of quality and continuous improvement.
- Stay current with evolving regulatory standards and industry best practices.
- Collaborate with R&D to achieve electrical safety and EMC certification.
- Partner with supplier quality team and new suppliers to ensure that components and materials meet specified quality standards. Participate in supplier qualification and audit processes as needed.
- Support complaints investigations, NCs and/or CAPA related to NPI complaints post-launch.
- Conduct DHF audits at each phase to ensure phase deliverables are complete.
- Review and approve engineering documentation, test protocols, and reports to ensure compliance and technical integrity.
- Identify opportunities for continuous improvement in product design and manufacturing processes.
- Lead or participate in initiatives to enhance product quality, reduce costs, and improve overall efficiency
- Certifications such as ASQ CQE (Americal Society for Quality Certified Quality Engineer), ASQ CSQE (Certified Software Quality Engineer), Six Sigma Black Belt or similar are a plus.
Calyxo, Inc. develops medical devices for kidney stone treatment. Its products are designed for use by urologists in hospitals and clinics to treat kidney stones more effectively, prioritizing patient safety and efficient procedures. The company works closely with leading U.S. urologists to translate clinical needs into devices, focusing on making treatments safer and easier for clinicians. Unlike some competitors, Calyxo emphasizes clinician collaboration and proven clinical relevance in its device development, backed by leadership with startup and product-launch experience. The goal is to improve patient care by delivering advanced devices that help urologists achieve better clinical outcomes and expand the devices’ reach through commercialization to healthcare providers.
Company Size
201-500
Company Stage
Series F
Total Funding
$137.2M
Headquarters
Pleasanton, California
Founded
2016
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Simplify's Take
What believers are saying
- Calyxo raised $40 million on April 14, 2026, extending commercialization runway.
- Two-year ASPIRE data showed 73% fewer healthcare consumption events versus standard ureteroscopy.
- Commercial infrastructure expansion and new studies should accelerate adoption through 2026.
What critics are saying
- FDA classified Calyxo's CVAC issue as a Class I recall in January 2026.
- Calyxo reported one death linked to intrarenal pressure mishandling in March 2025.
- Boston Scientific can crush Calyxo if urologists reject CVAC after the safety scare.
What makes Calyxo unique
- Calyxo's CVAC System offers aspiration-based stone removal, not standard basket extraction.
- The March 2026 ASPIRE and CLEARANCE data showed superior stone clearance and lower residual volume.
- FDA clearance in 2024 plus 40,000 treated patients validates real-world procedural adoption.
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Benefits
Health Insurance
401(k) Retirement Plan
401(k) Company Match
Paid Vacation
Stock Options
Growth & Insights and Company News
6 month growth
↓ -3%1 year growth
↓ -5%2 year growth
↓ -1%Valley reveals 2026 #gamechangers honorees ahead of ninth annual awards celebration. Pac-12, Inertia Fusion Energy, SavvyMoney, Calyxo, and Stanford Health Care Tri-Valley Named Among Region's Most Transformative Companies and Institutions DUBLIN, Calif. - 6 May 2026 - Innovation Tri-Valley Leadership Group (ITV) today announced the honorees for the ninth annual #GameChangers Awards - the Tri-Valley's signature celebration of breakthrough innovation, visionary leadership, and the companies and individuals reshaping one of the most dynamic regional economies in the world. The 2026 honorees represent the full breadth of the Tri-Valley's innovation ecosystem: a reinvented sports and entertainment powerhouse, a fusion energy company that may hold the key to the planet's clean energy future, a fintech platform changing how millions of Americans understand and manage credit, a medical device company attacking one of urology's most painful and persistent problems, and a healthcare institution that has fundamentally transformed how Tri-Valley residents access world-class care. The awards will be presented on Thursday, May 21, 2026, from 5:30 to 8:00 PM at The Roundhouse at Bishop Ranch in San Ramon. This year's honorees include: PAC-12 CONFERENCE - San Ramon Innovation in Sports & Entertainment Few institutions in American sports have undergone a transformation as dramatic - or as closely watched - as the Pac-12 Conference. Having relocated its operations to San Ramon, the Pac-12 is rewriting its own story from the heart of the Tri-Valley, building a next-generation model for collegiate sports and entertainment that leverages Silicon Valley's proximity, the Bay Area's media infrastructure, and a legacy brand that generations of fans across the western United States know and love. The Pac-12's reinvention is not just a sports story. It is a story about what it looks like when a storied institution bets on the Tri-Valley as the place to write its next chapter. INERTIA FUSION ENERGY - Livermore Innovation in Energy & Deep Technology Livermore has long been home to some of the most ambitious science in the world - and Inertia Fusion Energy is squarely in that tradition. Building on the landmark fusion ignition achieved at Lawrence Livermore National Laboratory in December 2022, Inertia Fusion Energy is working to translate that historic scientific breakthrough into a viable, commercially deployable clean energy technology. If successful, the implications are civilization-scale: abundant, carbon-free energy produced from the same physics that powers the stars. That this work is developing in Livermore is not a coincidence. It is the result of decades of scientific investment that the entire region has taken stake in. SAVVYMONEY - Dublin Innovation in Financial Technology The vast majority does not fully understand their credit score - a number that shapes their ability to buy a home, secure a loan, and build financial stability. SavvyMoney, headquartered in Dublin, is changing that. The company's credit score and financial wellness platform is embedded in the digital banking experiences of credit unions and financial institutions serving tens of millions of consumers nationwide, providing real-time credit insights, personalized offers, and the kind of financial clarity that was previously available only to those who knew where to look and what to look for. SavvyMoney's work is not just fintech. It's financial equity, shared at scale, and built in the Tri-Valley. CALYXO - Pleasanton Innovation in Biotechnology & Medical Devices Kidney stones affect one in ten Americans and represent one of the most painful and costly conditions in urology - with recurrence rates that make treatment a recurring challenge for millions of patients. Calyxo, based in Pleasanton, has developed a breakthrough medical device technology designed to dramatically improve the efficiency and outcomes of kidney stone treatment, reducing procedure time, improving stone clearance, and enabling patients to return to health faster. The company's technology is the product of deep clinical insight and rigorous engineering - and its trajectory from Pleasanton to surgical suites across the country is precisely the kind of innovation story the Tri-Valley was built to produce and tell. STANFORD HEALTH CARE TRI-VALLEY - Founders Award Transformative Impact on the Tri-Valley Innovation Ecosystem The annual Founders Award honors an individual or organization whose contribution to the Tri-Valley's innovation ecosystem transcends a single sector or a single year - whose presence has fundamentally changed what is possible for the region and the people who live here. This year, that recognition is given to Stanford Health Care Tri-Valley. When Stanford Health Care opened its Tri-Valley campus, it did not simply add another hospital to a growing region. It signaled to the world that the Tri-Valley was a place worthy of competitive institutional investment - and it delivered on that signal by bringing the clinical expertise, research capabilities, and care standards of one of the world's leading academic medical centers to the doorstep of Tri-Valley families. The impact has been profound: on patient outcomes, on the region's ability to attract and retain top talent, on the broader healthcare ecosystem, and on the confidence of every company and family that has chosen to build a home in the region. Stanford Health Care Tri-Valley has not just served this community. It has strengthened it and made life and living sought after in the Tri-Valley. The #GameChangers Awards - Nine Years of Honoring the Tri-Valley's Best Now in its ninth year, the #GameChangers Awards has become the most anticipated event on the Tri-Valley's innovation calendar - a high-energy reception and awards ceremony that unites the region's founders, funders, civic leaders, and entrepreneurs to honor the companies and individuals transforming the Tri-Valley into a global innovation hub. "The 2026 cohort is extraordinary - and equally emblematic of a Tri-Valley that is not waiting for the future to arrive," said Katie Marcel, CEO, Innovation Tri-Valley. "This region's innovation story is a huge contribution to the leadership of California. It is a bearer of hope for the world." The ninth annual #GameChangers Awards will feature a hosted reception and the presentation of this year's honorees in a program designed to energize and inspire everyone in the room. Tickets, sponsorship opportunities and more information are available at [email protected]. ###. ABOUT INNOVATION TRI-VALLEY LEADERSHIP GROUP Innovation Tri-Valley Leadership Group (ITV) is a collaborative network of corporate leaders, elected and civic officials, educators, and regional champions dedicated to advancing the Tri-Valley as a globally recognized hub of technology, entrepreneurship, and economic vitality. Spanning the cities of Dublin, Livermore, Pleasanton, San Ramon, and the Town of Danville, the Tri-Valley is home to two national research laboratories - Lawrence Livermore National Laboratory and Sandia National Laboratories - more than 700 technology companies, and a regional innovation economy generating $52 billion in GDP. ITV connects the dots between the public and private sectors, amplifies the region's breakthrough companies and people, and shapes the long-term economic future of one of the Bay Area's fastest-growing and most dynamic regions. Learn more at innovationtrivalley.org. MEDIA CONTACT
Calyxo, Inc., a medical device company redefining kidney stone treatment, today announced the closing of a $40 million Series F financing round, led by Ally ...
Calyxo raises $40m to advance kidney stone removal system. Calyxo intends to use the funds towards generating further clinical and economic evidence for its CVAC system for kidney stone clearance. Calyxo has raised $40m in a financing round; at the same time, the company has achieved a milestone of 40,000 kidney stone removal procedures completed with its central venous access catheter (CVAC) system. The Series F financing round was led by Ally Bridge Group and Janus Henderson Investors, with continued support from Questa Capital, Avidity Partners, and CRG. Calyxo's CVAC system provides continuous aspiration of stone fragments during and after laser lithotripsy to support more complete kidney stone clearance. The system obtained US Food and Drug Administration (FDA) clearance in March 2024. Calyxo plans to apply the latest funds towards clinical and health economic evidence generation through ongoing and future studies to evaluate the system's long-term outcomes and downstream healthcare utilisation, along with making expansions to its commercial infrastructure. Past research of Calyxo's CVAC has found that 95% of patients experienced no adverse events (AEs) following its use alongside steerable ureteroscopic renal evacuation (SURE) for kidney stone clearance, versus 83.5% who received standard ureteroscopy. Coinciding with the latest financing round, Calyxo shared that it has recently completed 40,000 kidney stone removal procedures using its CVAC system. Calyxo CEO, Joe Catanese, commented: "Real-world experience, together with an established body of clinical evidence, indicates that the CVAC system is moving beyond early adoption and becoming an important part of the standard of care in kidney stone treatment. This financing allows us to move faster in advancing our technology and expanding the evidence base to further improve patient care." According to the American Urological Association (AUA), approximately 10% of people in the US will have a kidney stone at some point in their lives. In the broader kidney care space, funding is an ongoing challenge. An American Society of Nephrology (ASN) report from November 2025 highlights that the US funding imbalance in kidney care has stalled progress, leaving dialysis as the default therapy for kidney failure, despite its "debilitating impact" and poor survival outcomes. To turn the tide on poor survival outcomes for conditions such as end-stage kidney disease (ESKD), advocates are growing more vocal about shifting the focus to kidney care, and have urged the World Health Organization (WHO) to classify kidney disease as a non-communicable disease priority globally. Give your business an edge with its leading industry insights.
Calyxo, a medical device company focused on kidney stone treatment, has closed a $40 million Series F financing round led by Ally Bridge Group and Janus Henderson Investors. Questa Capital, Avidity Partners and CRG also participated. The funding follows a milestone of 40,000 patients treated with Calyxo's CVAC System, an aspiration-based stone removal device. The system uses irrigation and vacuum aspiration to continuously clear stone fragments during procedures, enabling more complete stone clearance. Proceeds will support commercial expansion, clinical evidence generation through ongoing studies evaluating long-term outcomes, and continued innovation in kidney stone care. The CVAC System received FDA clearance in 2024 and is positioned as an all-in-one solution for minimally invasive kidney stone removal.
PLEASANTON, Calif.--(BUSINESS WIRE)--Calyxo, Inc., a medical device company developing innovative solutions for patients with kidney stones, has announced that positive study results for its CVAC System were presented last week at the American Urological Association (AUA) Annual Meeting in San Antonio. The CVAC System, a revolutionary technology that is designed for complete kidney stone removal, was the focus of the prospective, randomized, multi-center ASPIRE study, which compared the safety and efficacy of steerable ureteroscopic renal evacuation (SURE) vs ureteroscopy (URS) with basketing. The 30-day results of the ASPIRE study were presented at the AUA Meeting by urologist Thomas Chi, MD of the University of California, San Francisco. In 101 patients, SURE demonstrated statistically superior stone clearance and significantly lower residual stone volume compared to standard URS. Unlike standard URS, the CVAC System achieved these results independent of baseline stone burden. Safety was comparable between groups