Staff R&D Engineer

Shockwave Medical Santa Clara , CA 95050

Posted 1 week ago

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 Staff R&D Engineer will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Staff R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization.

Essential Job Functions

  • Design and develop product(s) in compliance with the companys 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 companys quality system.
  • Responsible for knowing and planning activities consistent the companys 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.

Requirements

  • Bachelors Degree (Masters or PhD preferred) in Mechanical, Biomedical Engineering, or equivalent experience.
  • Minimum of 8 years experience in engineering preferably in the medical device industry.
  • 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.
  • 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.

Benefits

Shockwave Medical offers a competitive total compensation package including comprehensive benefits (medical, dental, vision) as well as pet insurance and student loan refinancing support.

EEO Employer

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VIEW JOBS 9/22/2020 12:00:00 AM 2020-12-21T00:00 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 Staff R&D Engineer will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Staff R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization. Essential Job Functions * 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 (Master's or PhD preferred) in Mechanical, Biomedical Engineering, or equivalent experience. * Minimum of 8 years' experience in engineering preferably in the medical device industry. * 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. * 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. Shockwave Medical offers a competitive total compensation package including comprehensive benefits (medical, dental, vision) as well as pet insurance and student loan refinancing support. EEO Employer Shockwave Medical, Inc. Santa Clara CA

Staff R&D Engineer

Shockwave Medical