Full-Time
Quality Engineer
Capstan Medical
51-200 employees
Catheter-based heart valve replacement via robotics
No salary listed
Santa Cruz, CA, USA
In Person
 QA & Testing (1) |
|---|
Get referred to Capstan Medical
See people who can refer or advise you
- 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.
- 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.
- 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's Take
What believers are saying
- Series C funding of $110M in December 2024 accelerates clinical trials and R&D expansion.
- First-In-Human TMVR trial started February 2025 with recruiting in Australia, Chile, and New Zealand.
- Team includes 75+ experts from Intuitive Surgical, Boston Scientific, and Abbott with decades of robotics experience.
What critics are saying
- FDA Class III approval requires 10+ implants across 4 sites before 2027; only 2 human cases exist as of March 2025.
- Medtronic's dominant market share and robotics portfolio enable rapid competitive response, threatening Capstan's FDA pathway.
- Single supplier Admedes for nitinol implants creates supply chain failure risk if quality control fails during scaling.
What makes Capstan Medical unique
- Capstan Medical combines surgical robotics, catheter implants, and robotic navigation for heart valve replacement.
- It delivered the world's first robotic-catheter mitral valve replacements in human patients in March 2025.
- The platform targets both mitral and tricuspid valve disease with a minimally invasive alternative to open-heart surgery.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Growth & Insights and Company News
6 month growth
↓ -3%1 year growth
↑ 3%2 year growth
↑ 28%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
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.