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Principal R&D Engineer - Balloon Technology

Company: Shockwave Medical, Inc.
Location: Santa Clara
Posted on: November 15, 2021

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 Overview

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 regulatory requirements.
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 goals.
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 needs.
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.
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 commercialization.
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 company's products.
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 organizations.
Ability to operate independently and adaptability to changing requirements.
Ability to work in a fast-paced environment, managing multiple priorities.
Previous experience managing cross functional teams is preferred.
Proficiency in SOLIDWORKS and Design of Experiments is a strong plus.
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

EEO Employer

Keywords: Shockwave Medical, Inc., Santa Clara , Principal R&D Engineer - Balloon Technology, Engineering , Santa Clara, California

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