Full-Time

Quality Engineer

Capstan Medical

Capstan Medical

51-200 employees

Catheter-based heart valve replacement via robotics

No salary listed

Santa Cruz, CA, USA

In Person

Bachelor's, Master's

Category
Manufacturing Quality & Test (1)
Required Skills
Metrology

Get referred to Capstan Medical

See people who can refer or advise you

Requirements
  • Bachelor's degree in Engineering or a related technical field.
  • Knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices.
  • Experience working in a cleanroom manufacturing environment.
  • Experience with nonconforming material investigations and implementing effective CAPAs.
  • Strong understanding of quality management systems.
  • Excellent problem-solving skills and ability to apply root cause analysis methodologies.
  • Detail-oriented with effective organizational and documentation skills.
  • Strong communication and collaboration skills to work cross-functionally and interact with technicians, auditors, and third parties.
  • Attention to detail, with a focus on accuracy and precision in quality-related activities.
  • Ability to work independently in a fast-paced organization with competing priorities.
Responsibilities
  • Provide quality engineering support to the manufacturing line and support finished goods release for structural heart implant, delivery, and robotic devices.
  • Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices.
  • Provide guidance on sterilization processes and validations to ensure product safety and compliance.
  • Facilitate sterilization activities including batch release, sterilization validation, and coordination with third party sterilizers.
  • Oversee packaging validation activities to ensure product integrity and stability during storage and transportation.
  • Participate in finished goods release processes, ensuring compliance with release criteria and applicable regulatory requirements.
  • Oversee product quality during all stages of production in a cleanroom manufacturing environment.
  • Lead and support investigations into nonconforming materials and products (NCRs), working closely with cross-functional teams including Manufacturing and Engineering, identifying root causes, ensuring timely resolution, and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence.
  • Participate in materials decision making as a member of Material Review Board
  • Collaborate with cross-functional teams, including Manufacturing and Engineering, to resolve quality issues and identify opportunities for process improvement and efficiency gains within the manufacturing environment.
  • Perform audits of manufacturing processes, including inspections, testing, and documentation, to identify areas for improvement and ensure adherence to quality standards.
  • Maintain accurate and up-to-date documentation related to quality control processes, inspection results, metrology records, nonconformance reports, and corrective actions.
  • Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.
  • Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings.
Desired Qualifications
  • Master's degree is a plus.

Capstan Medical develops catheter-based heart valve replacement solutions that use surgical robotics to guide valve implants through small blood vessels, avoiding open-heart surgery. Its system combines implants, delivery catheters, and robotic navigation to treat mitral and tricuspid valve disease with minimally invasive methods. The company differentiates itself by integrating robotic guidance with catheter delivery and by pursuing less invasive replacements for structural heart disease, evidenced by the world’s first robotic-catheter mitral valve replacement in humans. Its goal is to provide safer, quicker-recovery treatments for patients with valve disease.

Company Size

51-200

Company Stage

Series C

Total Funding

$141.4M

Headquarters

Santa Cruz, California

Founded

2020

Get referred to Capstan Medical

See people who can refer or advise you

Simplify Jobs

Simplify's Take

What believers are saying

  • Capstan raised $110 million in December 2024, funding trials and manufacturing scale-up.
  • The company plans first-in-human mitral trials in 2025 and pivotal work in 2026.
  • Nitinol partnerships with Admedes and supplier depth reduce execution risk on complex implants.

What critics are saying

  • Abbott, Edwards, and Medtronic already dominate structural heart with approved mitral and tricuspid products.
  • Capstan still remains preclinical for tricuspid, leaving one valve franchise unvalidated through 2026.
  • If 2026 EFS or pivotal timelines slip, customers and investors lose confidence before FDA submission.

What makes Capstan Medical unique

  • Capstan completed first-in-human robotic-assisted transcatheter mitral valve replacements on March 6, 2025.
  • Its platform combines novel implants, catheter delivery, and integrated robotics for mitral and tricuspid disease.
  • CEO Maggie Nixon says gen-two robot comes online in 2026, preserving platform leadership.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Growth & Insights and Company News

Headcount

6 month growth

-6%

1 year growth

-4%

2 year growth

22%
VNTR
Feb 21st, 2026
Pharma giants return to the M&A table: what $38B in biotech exits signals.

Pharma giants return to the M&A table: what $38B in biotech exits signals. February 21, 2026 Roughly $38 billion in announced and completed biotech M&A across 2024 and early 2025 marks one of the strongest acquisition cycles since the pre-pandemic boom, even as AI absorbs most of the market's mindshare. While capital continues to chase foundational AI models and infrastructure, large pharmaceutical companies are quietly reasserting themselves as the most reliable source of liquidity for life sciences investors. The contrast is sharp: public enthusiasm has shifted to compute and chips, but strategic buyers in biotech are writing substantial checks for assets that show clinical maturity and clear paths to differentiation. Several transactions underscore the scale and seriousness of this renewed activity. Eli Lilly's $2.4 billion acquisition of Orna demonstrated major pharma's willingness to pay premium valuations for emerging in vivo technology platforms rather than wait for later-stage de-risking. AbbVie reinforced the trend with its $2.1 billion purchase of Capstan, a move that signals continued appetite for next-generation delivery systems capable of supporting pipeline expansion. Both deals highlight a pattern: strategic acquirers are targeting platforms with clinical validation and enough optionality to influence multi-year R&D planning. The most significant transaction in the recent wave came from Johnson & Johnson, which executed a $3.05 billion all-cash acquisition of Halda. The cash-only structure is notable. In an environment where equity markets remain choppy and biotech IPOs are rare, cash consideration provides a clear and immediate exit - precisely what many investors have been waiting for after two years of constrained liquidity. It also reiterates that large pharma balance sheets remain strong and that buyers prefer straightforward transactions without contingent components. These deals are occurring even as the broader financing environment remains uneven. Venture funding share for biotech has declined relative to AI, and public markets have yet to fully reopen for early-stage or mid-cap life sciences companies. But M&A, not IPOs, is currently the mechanism delivering real liquidity. For investors, that distinction matters more than sector-level sentiment. The takeaway is direct: strategic acquirers are active, capital is being deployed, and exits are happening at meaningful valuations. The window is selective, but it is open. For portfolios holding clinical-stage assets or differentiated platforms, the current cycle offers a viable path to liquidity - and one that appears to be strengthening rather than fading. February 21, 2026 VNTR Research Team

WTWH Media LLC
Feb 23rd, 2025
Capstan Medical CEO on Nitinol, Funding

Capstan Medical's CEO, Maggie Nixon, discusses the company's work with nitinol in developing mitral heart valve implants and their collaboration with suppliers like Admedes. She highlights the importance of partnerships in manufacturing and shares leadership insights since becoming CEO. Capstan, which emerged from Occam Labs, has grown significantly. Nixon also praises Intuitive Ventures for their continued investment and advises engaging with them at conferences for potential deals.

Lookout Local, Inc.
Dec 11th, 2024
Santa Cruz medtech company raises $110 million for its efforts to treat heart disease

Santa Cruz-based Capstan Medical is poised to take the next step in its treatment of heart valve disease, announcing a new $110 million funding round as it prepares for patient trials next year.

HIT Consultant
Dec 11th, 2024
Capstan Medical Secures $110M for Heart Valve Tech

Capstan Medical has raised $110M in a Series C funding round led by Eclipse, with participation from Yu Galaxy, Intuitive Ventures, and Gideon Strategic Partners. The funds will advance their minimally invasive heart valve treatment, which includes novel implants, advanced catheter technology, and a robotic platform. The investment will accelerate clinical trials, expand R&D, and scale operations to improve treatment options for heart valve disease.

HIT Consultant
Dec 11th, 2024
Capstan Medical Raises $110M to Advance Minimally Invasive Heart Valve Treatment

- Capstan Medical, a medical technology company developing innovative solutions for heart valve disease secures $110M in a Series C funding round led by Eclipse with participation from existing investors Yu Galaxy and Intuitive Ventures, and new investment from Gideon Strategic Partners.