Sr. R&D Systems Engineer
Company: Shockwave Medical
Location: Santa Clara
Posted on: August 3, 2022
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
- Coordinate with R&D Design Engineers in the development of
- 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
- Support quality audits and follow-up activities.
- Provide support to Operations as required.
- Manage development of system variants for specific applications
- 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
- Effective communication skills with all levels of management
- Ability to work in a fast-paced environment, managing multiple
- 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
Keywords: Shockwave Medical, Santa Clara , Sr. R&D Systems Engineer, Other , Santa Clara, California
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