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 in the coronary and peripheral 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.  

• Bachelor’s Degree in Mechanical or Biomedical (or similar) Engineering and 10 years’ experience in engineering OR a Master’s Degree and 8 years’ experience in engineering OR a PhD and 6 years’ experience in engineering.
• 3 years’ experience in early-stage (pre-design freeze) catheter and/or leads-based cardiovascular device development, preferred.
• Knowledge of coronary and vascular anatomy, physiology, and model development is a strong plus.
• Minimum 1 year as team or project technical lead.
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
• Strong understanding of data analysis and statistics including design of experiments, Gage R&R, capability, etc. is a strong plus.
• Strong teamwork skills and demonstrated ability to work closely with cross functional partners.
• 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.
• Occasional travel up to 10%
• Employee may be required to lift objects up to 25 lbs.

Market Range:

$144,000 - $180,000
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