LOCATION
Galway, Ireland or Nijmegen, Netherlands
TECHNOLOGY
Percutaneous Ventricular Assist Device (pVAD)
COMPANY HQ
Galway, Ireland and Nijmegen, Netherlands
COMPANY SIZE
11-50 Employees
POSITIONOVERVIEW
CardiacBooster raised a €16M Series A financing round from marquee investors including SANTÉ and Lightstone Ventures to accelerate product development for its percutaneous ventricular assist device (pVAD). The capital will drive the product through design freeze and into our first in human feasibility study.
- Please see these MedTech Money podcast episodes for more information on Board Members James Eadie of SANTÉ Ventures and Hanson Gifford of Lightstone Ventures
We have partnered with Patrick Griffin, Vice President of R&D, and Florian Ludwig, CEO, to hire our Lead Valve R&D Engineer. The candidate will have expertise in the biologic use of polymers and an understanding of fluid dynamics related to cardiac valve design. Our Engineer will be a highly technical, hands-on position with the potential to grow and lead a team and will be based in Galway or Nijmegen with relocation assistance available for the right candidate.
POSITIONDETAILS
- Technical Leadership: Provide technical leadership and guidance in the design, development, and optimization of polymeric in-vivo valves for medical devices. Collaborate with a team of engineers to foster a culture of innovation and excellence. Drive the advancement of valve technology, integrating emerging materials and design concepts into product development strategies.
- Materials Expertise: Possess deep knowledge and expertise in polymeric/synthetic or pericardial materials suitable for in-vivo valve applications. Evaluate and select appropriate materials considering factors such as biocompatibility, durability, mechanical properties, and manufacturability. Stay updated with the latest advancements in polymeric materials and their application in medical devices.
- Design and Development: Lead the design and development of temporary in-vivo valves, ensuring compliance with regulatory requirements and industry standards. Collaborate with cross-functional teams, including test and mechanical engineers, blood specialists, material scientists, design assurance and clinicians, to develop innovative and effective valve solutions.
- Apply engineering principles and computational modelling techniques to optimize valve performance, blood flow and hemodynamics, functionality, integrity and durability.
- Analyse test data, identify issues, and implement necessary design modifications to ensure product performance and safety.
- Prototyping and Testing: Utilize rapid prototyping techniques to develop valve prototypes for in-vitro and in-vivo testing. Design and oversee testing protocols to evaluate valve functionality, durability, and biocompatibility.
- Strategy and Planning: Contribute to the development of the overall R&D strategy and roadmap for polymeric valve projects. Collaborate with cross-functional teams, including product management, regulatory affairs, and clinical experts, to define project objectives, timelines, and resource requirements. Ensure alignment with corporate goals and market needs.
- Regulatory Compliance and Quality Assurance: Stay up to date with relevant regulatory requirements, including FDA guidelines, ISO standards, and other global regulations specific to polymeric medical devices. Ensure compliance with applicable standards throughout the development process. Provide guidance and support for regulatory submissions, design verification, validation activities, and quality control processes.
- Collaboration and Stakeholder Management: Collaborate with internal and external stakeholders, including engineering teams, clinical experts, manufacturing partners, and regulatory authorities. Build strong relationships with key opinion leaders and industry experts in the polymeric valve field. Effectively communicate project updates, technical insights, and recommendations to senior management and other stakeholders.
- Project Management: Lead cross-functional project teams, overseeing project planning, resource allocation, and progress tracking. Ensure projects are executed within defined timelines, budgets, and quality standards. Proactively identify and mitigate risks and issues that may impact project delivery.
- Master’s or Ph.D. degree in Biomedical Engineering, Polymer Science, Mechanical Engineering, or a related field, with a strong academic background and significant industry experience.
- Extensive experience in medical device R&D, with a focus on circulatory system valve design and development.
- Proven track record of successful development and commercialization of polymeric medical device products, preferably in the cardiovascular field.
- Deep knowledge and expertise in valve materials suitable for in-vivo applications, including biologic tissue, biocompatible polymers, polymer processing techniques, and material characterization methods.
- Knowledge and understanding of valve blood flow and hemodynamics
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and advanced engineering analysis tools (e.g., Abaqus, ANSYS, COMSOL) for complex design and simulation.
- Comprehensive understanding of relevant industry standards and regulations, such as ISO 13485, ISO 5840, ISO14971, MDR, FDA requirements, and international market regulations for polymeric medical devices.
- Excellent communication skills in English and preferably one other European language
- Strong leadership skills, with the ability to inspire and mentor junior engineers.
- Excellent problem-solving abilities, strategic thinking, and the capacity to drive innovation.
- Exceptional communication skills, both written and verbal, with the ability to influence and collaborate effectively across functions and levels of the organization.
- Demonstrate an established vendor network relevant to the device type.
- Experience with developing tests necessary to measure the performance of valve function where established techniques or international standards may not yet exist.
- Working knowledge of data interrogation, DOE and applicable statistics.
- Detail-oriented mindset with a focus on quality, compliance, and attention to regulatory requirements.
- Demonstrated project management experience, including planning, resource allocation, risk management, and milestone tracking.
- Must be currently living in, or able to relocate to Galway, Ireland or Nijmegen, Netherlands
- Knowledge of the patent process is an advantage.
COMPANYOVERVIEW
CardiacBooster is a medical device company developing a new and innovative percutaneous ventricular assist device (pVAD). pVADs are used by interventional cardiologists to stabilize patients in times of acute heart failure (cardiogenic shock) or patients undergoing high-risk coronary procedures (high-risk PCI). Our objective is to overcome the limitations of current assist devices by providing interventional cardiologists with a more effective and less invasive device.
View PDF
Company Overview
APPLY NOW
Lead Valve R&D Engineer
Galway, Ireland or Nijmegen, Netherlands
PRESENTED BY
Lifeblood™ supports global MedTech Startups with Talent Acquisition and Fundraising Strategies. We build full-scale startup teams from Board and C-level executives to entry-level individual contributors and from early-stage R&D through multi-national commercialization phases.Approaching two decades of experience in the MedTech industry, our talent acquisition services and team-building efforts are the results of 2,000+ successful hires for 500+ companies in 6 continents. We have facilitated more than $220 million for MedTech startups with our fundraising strategies and global investor network.
People and money are the lifeblood capital of startups. Learn from our entrepreneurs and investors as we demystify raising and investing capital on our MedTech Money Podcast Series.
