Staff R&D Engineer

Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the recent acquisition of Neovasc and their innovative Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina - long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. Together, we are working to bring these patients relief from their symptoms and hopefully improve their quality of life.

• Design and develop product(s) in compliance with the company's Design Control requirements and applicable regulatory requirements.
• Prototype and develop proof of concept designs and bench models to test these concepts in a simulated environment.
• Develop, validate and maintain test methods.
• Develop new products based on defined user needs.
• Responsible for translating user needs into design inputs/product specifications.
• Develop and maintain technical documentation such as drawings for components and assemblies for products.
• Support the design, development, and qualification of products, equipment and processes.
• Performs testing, analyze results and provides recommendations for design selection.
• Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping pilot operation and design verification and validation activities.
• Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.
• Participates in technical design reviews to ensure all design inputs and user needs are met.
• Supports product development teams in executing projects from concept to commercialization.
• Supports base business and/or continuous improvement projects.
• Responsible for ensuring proper documentation consistent with company's quality system.
• Responsible for knowing and planning activities consistent the company's quality policy and quality objectives.
• Supports pilot manufacturing as necessary.
• Identify and maintain relationships with suppliers to ensure the delivery of superior components and services.
• Enhance the intellectual property position of the company via invention disclosures and patent applications.
• Supports company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.
• Other duties as assigned.

• Bachelor's Degree in Mechanical or Biomedical Engineering with 8 years' experience in engineering or a Master's Degree in Mechanical or Biomedical Engineering and 6 years' experience in engineering.
• Engineering experience in the medical device industry.
• Knowledge of disposable peripheral and coronary device design, material selection, and testing.
• Experience in design and development of cardiovascular implants and delivery systems (stents, heart valves, etc.)
• Experience with balloon expandable and/or self expanding implants is a plus
• Experience with implant finite element analysis and durability testing is a plus
• 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.
• Experience with CAD software (i.e. Solidworks)
• Experience with statistical analysis and design of experiments (DOE) is a plus.
• Effective communication skills, written and verbal, 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.
• Experience developing disposable medical devices.
• Employee may be required to lift objects up to 25lbs.

Market Range: $107,000 - $134,000
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