Principal R&D Engineer - Balloon Technology
Company: Shockwave Medical, Inc.
Location: Santa Clara
Posted on: November 15, 2021
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.
The Principal R&D Engineer will use technical skills in the
development of innovative products to treat peripheral, coronary,
and heart valve diseases. The Principal R&D Engineer will
participate on multiple cross-functional development teams that
manage projects from concept through commercialization. They will
support product development efforts in our IVL balloon related
devices as well as develop new balloon technologies to address the
anticipated needs of future applications.
Essential Job Function
Provide technical leadership for projects including managing
technology development teams.
Design and develop product(s) in compliance with the company's
Design Control requirements and consistent with applicable
Partner with the Adv. R&D and PDP teams to translate finished
device requirements to the balloon component level.
Survey emerging technologies in the balloons and polymer science
space and explore novel applications to support company strategic
Identify practical ways to apply new balloon/polymer technologies
to improve current and next generation products.
Execute a long-term strategy with Technologies Development Team for
examining new designs, materials as well as processing methods for
next-generation balloon concepts.
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
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
Analyzes, evaluates, sources, and coordinates the procurement of
new materials to support prototyping and pilot operation as well as
to maintain relationships with suppliers to ensure the delivery of
superior components and services.
Participate as SME or core team member on product development
team(s) that manage projects from concept through
Responsible for ensuring proper documentation (e.g., component and
assembly drawings) consistent with company's quality system.
Responsible for knowing and planning activities consistent the
company's quality policy and quality objectives.
Develop protocols/reports and perform product in-vitro, in-vivo as
well as verification and validation testing.
Enhance the intellectual property position of the company via
invention disclosures and patent applications.
Maintain current knowledge of competitive technologies in addition
to medical, technical, and biomedical developments related to
Support company goals and objectives, policies and procedures,
Quality Systems, and FDA regulations.
Other duties as assigned.
Bachelor's Degree in Mechanical Polymer Science or other relevant
engineering/technical degree and 10 years' experience in the
medical device industry or a Master's Degree and 8 years'
experience in medical devices.
3+ years of experience in polymer product development including
experience with balloon blow molding.
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.
Proven track record in technology development and/or early-stage
R&D; capable of planning and executing tasks for progressing
towards a loosely defined research goal.
Proven successful project leadership skills.
Effective communication skills with all levels of management and
Ability to operate independently and adaptability to changing
Ability to work in a fast-paced environment, managing multiple
Previous experience managing cross functional teams is
Proficiency in SOLIDWORKS and Design of Experiments is a strong
Employee may be required to lift objects up to 25lbs.
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: ESPP, Calm App, Pet Insurance, Student Loan Refinancing,
Spot Bonus awards
Keywords: Shockwave Medical, Inc., Santa Clara , Principal R&D Engineer - Balloon Technology, Engineering , Santa Clara, California
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