Quasarmedical
Senior Catheter Engineer
This position will lead new catheter-related design projects for tier-1 customers, from concept to completion.
The ideal candidate will possess a strong background in medical device design and development, particularly with catheters, and will thrive in a customer-facing environment that demands both hands‑on R&D expertise and project management capabilities.
Responsibilities
Manage and lead new catheter design projects for tier-1 customers, ensuring successful execution from initiation to delivery
Serve as the primary technical contact for customers, understanding their needs and translating them into innovative design solutions
Develop and refine catheter designs, considering performance, manufacturability, cost, and regulatory requirements
Oversee the entire project lifecycle, including planning, scheduling, resource allocation, risk management, and stakeholder communication
Collaborate effectively with various global sites and internal interfaces (e.g., NPD, NPI, BD, QA) to ensure seamless project progression
Contribute to the development of electro‑mechanical medical device assemblies, particularly those integrated with catheter systems
Ensure all designs and project activities comply with relevant medical device regulations and quality standards
Present project updates, design reviews, and technical solutions to internal teams and external customers
Requirements Education: Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical field.
Experience:
At least 7-10 years of progressive experience in the development of medical devices
At least 4 years of demonstrated hands‑on experience in the design and development of catheters and delivery systemsExperience with the development electro‑mechanical medical device assembly – advantage
Proficiency in the development lifecycle of medical devices and catheters, from conceptual design all the way to verification and validation (V&V)
Experience working in a quality‑controlled environment under ISO 13485, including documentation work
Familiarity with global regulatory requirements for medical devices (e.g., FDA, CE Mark)
Proven track record in managing complex design projects from concept to commercialization
Experience working in a customer‑facing role, including technical presentations and relationship management – Advantage
Skills
Strong proficiency in CAD software (e.g., SolidWorks or other) for design and modelling
Excellent project management skills, including planning, execution, and monitoring
Exceptional communication and interpersonal skills, capable of effectively interacting with customers and internal cross‑functional teams across global sites
Deep understanding of materials and manufacturing processes
Problem‑solving aptitude with a keen eye for detail and a commitment to quality
Ability to work independently and as part of a team in a fast‑paced, dynamic environment
Willingness for frequent travel inside the US and abroad (EU, Israel, APAC)
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The ideal candidate will possess a strong background in medical device design and development, particularly with catheters, and will thrive in a customer-facing environment that demands both hands‑on R&D expertise and project management capabilities.
Responsibilities
Manage and lead new catheter design projects for tier-1 customers, ensuring successful execution from initiation to delivery
Serve as the primary technical contact for customers, understanding their needs and translating them into innovative design solutions
Develop and refine catheter designs, considering performance, manufacturability, cost, and regulatory requirements
Oversee the entire project lifecycle, including planning, scheduling, resource allocation, risk management, and stakeholder communication
Collaborate effectively with various global sites and internal interfaces (e.g., NPD, NPI, BD, QA) to ensure seamless project progression
Contribute to the development of electro‑mechanical medical device assemblies, particularly those integrated with catheter systems
Ensure all designs and project activities comply with relevant medical device regulations and quality standards
Present project updates, design reviews, and technical solutions to internal teams and external customers
Requirements Education: Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical field.
Experience:
At least 7-10 years of progressive experience in the development of medical devices
At least 4 years of demonstrated hands‑on experience in the design and development of catheters and delivery systemsExperience with the development electro‑mechanical medical device assembly – advantage
Proficiency in the development lifecycle of medical devices and catheters, from conceptual design all the way to verification and validation (V&V)
Experience working in a quality‑controlled environment under ISO 13485, including documentation work
Familiarity with global regulatory requirements for medical devices (e.g., FDA, CE Mark)
Proven track record in managing complex design projects from concept to commercialization
Experience working in a customer‑facing role, including technical presentations and relationship management – Advantage
Skills
Strong proficiency in CAD software (e.g., SolidWorks or other) for design and modelling
Excellent project management skills, including planning, execution, and monitoring
Exceptional communication and interpersonal skills, capable of effectively interacting with customers and internal cross‑functional teams across global sites
Deep understanding of materials and manufacturing processes
Problem‑solving aptitude with a keen eye for detail and a commitment to quality
Ability to work independently and as part of a team in a fast‑paced, dynamic environment
Willingness for frequent travel inside the US and abroad (EU, Israel, APAC)
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