R&D Catheter Engineer

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS : DO NOT CONTACT.

Overview :

Position Overview : Catheter R&D Engineer will be a key contributor to the design and development of next generation Intravascular Lithotripsy (IVL) devices. Contribute as part of a cross‐functional team in product design and development, process development and optimization, and testing to support new product development.

Responsibilities :

• Provide technical leadership for projects in the coronary vascular space.
• Provide mentorship to other engineers and assignments to technicians as required.
• Collaborate cross-functionally to gather and define user needs for new products
• Prototype and develop proof of concept designs, disease models and test methods based on the defined user needs and requirements.
• Solve challenging and complex technical problems during the new product development process.
• Work with clinical and scientific advisors as well as Key Opinion Leaders in translating clinical needs into design solutions while utilizing these resources to develop and optimize product design.
• Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation.
• Develop protocols, test methods, and reports, and perform product assessments on benchtop, in-situ, and in-vivo to prove and de-risk viability and feasibility of new product designs.
• Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
• Enhance the intellectual property position of the company via invention disclosures and patent applications.
• Participate as SME on product development team(s) that manage projects from concept through transfer to PDP team.
• Design and develop product(s) in compliance with the company’s Design Control requirements and consistent with applicable regulatory requirements.
• Ensure proper documentation consistent with the company’s quality system.
• Responsible for knowing and planning activities consistent with the company’s quality policy and quality objectives.
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products.
• Responsible for component and assembly documentation for new products being developed.
• Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.
• Other duties as assigned.

Qualifications :