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Sr. R&D Systems Engineer

Company: Shockwave Medical
Location: Santa Clara
Posted on: August 3, 2022

Job 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.Position OverviewThe Sr. R&D Systems Engineer will use design and technical skills to serve as the technical subject matter expert (SME) for the Shockwave Medical IVL system and will work with cross-functional teams to develop cost-effective, reliable, high-quality systems that satisfy customer needs and drive business strategies. The R&D Systems Engineer will identify robust system architectures that are scalable, manufacturable, reliable, and serviceable, as well as support R&D design teams to develop interface specifications and requirements, and provide technical support to other departments including marketing, customer service, regulatory, quality, marketing, and operations.Essential Job Functions

  • Provide technical support to marketing for system integration and product management related projects.
  • Develop technical specifications from specific user requirements, and engineering evaluation.
  • Create and release Product Specifications, Document Change Orders, Test Protocols, and other relevant engineering documentation in the company Product Lifecycle Management repository.
  • Coordinate with R&D Design Engineers in the development of design concepts.
  • Establish and maintain coordination between systems team members and project stakeholders through targeted meetings, and regular report-outs to management.
  • Provide technical support to R&D electrical and mechanical teams for system design and integration.
  • Support regulatory filing preparation, reviews, and follow up questions.
  • Support quality audits and follow-up activities.
  • Provide support to Operations as required.
  • Manage development of system variants for specific applications and/or markets.Requirements
    • BS in Electrical/Electronic Engineering or Biomedical Engineering with 5+ years of product development experience, or an MS in Electrical/Electronic Engineering or Biomedical Engineering with 3+ years of product development experience.
    • Experience with EN60601-1 and collateral standards as they apply to medical electrical equipment.
    • Experience reviewing electronic schematics, and mechanical drawings and models.
    • Experience in the development of medical devices.
    • Experience in all product design phases from concept to production.
    • Effective communication skills with all levels of management and organizations.
    • Ability to work in a fast-paced environment, managing multiple priorities.
    • Operate as a team and/or independently while demonstrating flexibility to changing requirements.
    • Experience with Jama software is a strong plus
    • Experience with software lifecycle management processes and tools is a plus.
    • Employee may be required to lift objects up to 25lbs.BenefitsShockwave 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 balancePerks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awardsEEO Employer

Keywords: Shockwave Medical, Santa Clara , Sr. R&D Systems Engineer, Other , Santa Clara, California

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