Shockwave Medical Careers

Description

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.

Description

• Provide technical leadership for projects including managing engineering deliverables, team assignments within a project and project timelines.
• Mentor engineers and technicians in best practices and engineering fundamentals.
• Enhance intellectual property position of the company via invention disclosures and patent applications.
• Support a long-term strategy with Technologies Development Team for examining new designs, advanced materials and processing methods for next-generation ophthalmology device concepts. 
• Design and develop product(s) in compliance with the company’s Design Control requirements and consistent with applicable regulatory requirements.
• Prototype and develop proof of concept designs, disease models and test methods of testing these concepts in a simulated environment and develop new product designs based on the defined user needs.
• New product testing, including comparison testing with competitor products, bench testing, animals testing and clinical evaluation, and including protocol and test report documentation.
• 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.
• Participate as SME or core team member on product development team(s) that manage projects from concept through the technology development phase.
• Responsible for ensuring proper documentation consistent with company’s quality system.
• Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.
• Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
• 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.
• Provide regular updates of key milestones and issues to the project team as well as management.
• Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.
• Other duties as assigned.

• Minimum of 12 years’ experience in engineering, preferably in the medical device industry with a Master’s Degree in Materials Science, Polymer Science, Mechanical or  Biomedical Engineering. Required (PhD highly preferred).  
• Experience developing disposable medical devices.
• Knowledge of disposable peripheral and coronary device design, material selection, and testing.
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
• Experience in early-stage catheter based cardiovascular devices development is a strong plus.
• Effective communication skills with all levels of management and organizations.
• Operate independently and adaptability to changing requirements.
• Ability to work in a fast-paced environment, managing multiple priorities.
• Employee may be required to lift objects up to 25lbs.

Market Range:

$167,000 - $209,000
Exact compensation may vary based on skills, experience, and location.

Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer