Dir R&D Acoustics, Imaging & Modeling

Director, R&D (Acoustics, Imaging, & Modeling) - Shockwave Medical

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview :

The Director, R&D (Acoustics, Imaging and Computational Modeling) provides leadership and will use technical skills in the characterization of innovative products to treat peripheral, coronary, and heart valve diseases. As a Subject Matter Expert (SME), the Director, R&D will lead the design, testing, and implementation of our acoustic based systems as well as our imaging systems and computational modeling efforts. The Director, R&D will expand and advance the group to include imaging as well as modeling, thereby enabling the development of next generation smart devices. Additionally, the role directs suppliers, contract manufacturers, as well as Engineers and Technicians and is responsible for advancing our acoustic research and process development systems, resources, and project management activities associated with executing the company's goals and objectives.

Essential Job Functions :

• Expand the group to include additional acoustic engineers and technicians as well as imaging and computational engineers.
• Drive and / or lead the development of next generation smart devices that implement in situ monitoring capabilities including ultrasonic sensors.
• Promote and lead collaborations with universities to further advance our technology and device capabilities.
• Manage, lead, and mentor engineer(s) and / or technician(s); may include multiple level reporting structure.
• Mentor and advance a variety of development and engineering activities, which focus on acoustic measurement and characterization systems, imaging and computational modeling.
• Represent Shockwave on the International Standard Committee (IEC) to establish an IVL standard.
• Serve as an SME on cross-functional team projects to support acoustic characterization and design decisions.
• Responsible for performing as well as advancing and optimizing acoustic measurements using data acquisition systems, hydrophones, high speed cameras, and other equipment.
• Perform data processing and analysis to generate reports and presentations for all levels of management.
• Enhance intellectual property position of the company via invention disclosures and patent applications.
• Guide new product testing, including comparison testing with competitor products, bench testing, and clinical evaluation, and including protocol and test report documentation.
• Ensure that development activities are properly documented through lab notebook, history file, and other records.
• Manage outside vendors and contractors providing products or services.
• Create, maintain, and communicate project timelines for acoustic testing programs to support R&D projects.
• Interface with R&D, Regulatory, Quality, IT and other cross-functional stakeholders to ensure acoustic lab operations are compliant to company policies and regulatory standards.
• File regulatory reports for FDA, IEC, UL, et al.
• Proactively identify and resolve challenges which could significantly delay project timelines.
• Provide leadership, goal setting, communication and facilitation skills as needed to guide and motivate project team members.
• Ensure that products satisfy acceptable quality standards and customer needs with consensus from cross-functional groups.
• Review and approve documents as specified in Document Control SOP.
• Other duties as assigned.

Requirements :