Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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.
The Sr. R&D Engineer will use technical and leadership skills in the development of innovative products to treat peripheral and coronary vascular diseases. The Sr. R&D Engineer has the authority to identify solutions related to product design and manufacturing processes, identify and document product and component design as well as assembly and manufacturing process solutions. Must direct suppliers, contract manufacturers, technicians and assemblers, interface with vendors and support Manufacturing and R&D goals.
Essential Job Functions
Design and develop product(s) in full compliance with the company's Design Control requirements and consistent with FDA, SO and MDD requirements.
Develop catheters and catheter assemblies/subassemblies according to user needs, engineering principles and product specifications.
Perform process-related tasks to support pilot manufacturing. Manage process development and optimization activities during pilot manufacturing and transfer.
Participate on multiple cross-functional development teams that manage projects from concept through commercialization.
Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation.
Plans and develops initial fabrication steps and test programs for prototypes.
Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.
Execute protocols, collect data and maintain lab notebook according to company policy and quality system.
Analyzes test data and generate draft reports determining if designs meet functional and performance specifications for Design and Engineering review.
Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
Analyzes, evaluates, and recommends cost, design or process improvement ideas through product, vendor, and design changes
Enhance the intellectual property position of the company via invention disclosures and patent applications.
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.
A minimum of a Bachelor's Degree in Mechanical, Biomedical, or Plastics engineering. Master's degree preferred
Minimum of 7 years' experience in engineering preferably in the medical device industry.
Technical expertise in catheter product design, development, manufacturing and verification preferred
Must possess good interpersonal and communication skills, and work in a collaborative style.
Good technical skills and proven engineering problem solving ability.
Experience developing disposable medical devices.
Experience with 3D CAD (preferably Solidworks)
Knowledge of disposable coronary or peripheral vascular device design, material selection and testing.
Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
Experience with early stage catheter based cardiovascular devices development is a strong plus.
Ability to work in a fast-paced environment while managing multiple priorities
Operate as a team and/or independently while demonstrating flexibility to changing requirements.
Employee may be required to lift objects up to 25lbs or more.
Shockwave Medical offers a competitive total compensation package including comprehensive benefits (medical, dental, vision) as well as pet insurance and student loan refinancing support.
Shockwave Medical, Inc.