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.

Description

Position Overview

The Staff R&D Electrical Engineer, Systems will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Staff R&D Electrical Engineer, Systems will support product testing, sub-system/component qualification and design, and serve on multiple cross-functional initiatives for projects ranging from concept through commercialization.

Essential Job Functions

• Design and develop product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDD/MDR requirements
• Prototype and develop proof of concept designs and test methods in a simulated environment, and develop new product designs based on the defined user needs
• Analyze, evaluate, source, and coordinate the procurement of new materials to support product development and operational initiatives
• Participate on cross-functional teams that manage projects in various stages, from concept through commercialization and sustaining.
• 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
• Responsible for designing fixtures and sub-systems, aligned with project goals
• Responsible for execution of testing against recognized standards, such as 60601-1, 60601-1-2, and others associated with the electro-mechanical equipment in the medical device industry.
• Responsible executing projects consistent with the company’s priorities and strategic objectives
• Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP
• Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing
• Perform process-related design tasks to support transitioning designs into a manufacturing environment
• Identify suppliers and maintain relationships to ensure the delivery of superior components and services
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products
• Responsible for component and assembly documentation for new products being developed
• Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations
• Other duties as assigned
  

Requirements

• Bachelor’s degree in Electrical or Biomedical Engineering with 8+ years’ engineering experience in medical devices, or a master’s degree with 5+ years’ engineering experience in medical devices
• Experience with Altium circuit design CAD suite preferred
• Experience in analysis and testing of electronic circuits at the component level
• 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
• Working knowledge of IEC 60601-1, IEC 60601-1-2, and other collateral standards
• Experience designing, assembling, and qualifying fixtures used for design verification, bench testing, and manufacturing needs
• 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
• Employee may be required to lift objects up to 25lbs

Market Range: $144,000 - $180,000
Exact compensation may vary based on skills, experience, and location.

Benefits
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