R&D Engineer II (Process Development)

Company: Shockwave Medical, Inc.
Location: Santa Clara
Posted on: November 1, 2024

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.DescriptionPosition OverviewThe R&D Engineer II will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The R&D Engineer II will focus on process development for the engineering team, providing oversight to pilot manufacturing/testing, and see products transition from development into full production. This position will participate on multiple cross-functional development teams that focus on process optimization, sustaining, and design support. The R&D Engineer II will develop, validate, and implement various processes by working closely with research/development, operations, regulatory, and quality teams.Essential Job Functions

• Support the development of product(s) for manufacturing in full compliance with the company's Design Control requirements and consistent with FDA, ISO, and MDR requirements.
• Work on prototype and develop designs, processes, and test methods in support of new product designs scaling for commercialization.
• Represent R&D on manufacturing-related project activities, including internal and external requests.
• Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation.
• Participate on cross-functional development team that manage projects from concept through commercialization.
• Responsible for ensuring proper documentation consistent with company's quality system.
• Responsible for knowing and planning activities consistent with the company's quality policy and quality objectives.
• Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP.
• Write protocols/reports and perform product verification and validation testing.
• Perform process-related design tasks to support pilot manufacturing.
• Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
• 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 Mechanical or Biomedical Engineering with 2+ years' experience in engineering or a master's degree in Mechanical or Biomedical Engineering with 1 year of engineering experience preferred.
  • Engineering experience in the medical device industry is highly preferred.
  • Knowledge of disposable peripheral and coronary device design, material selection, and testing preferred.
  • 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.
  • Effective communication skills with all levels of management and organizations.
  • Ability to work in a fast-paced environment while 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:$98,000 - $115,000Exact compensation may vary based on skills, experience, and location.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 balance.Perks: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards.EEO Employer
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Keywords: Shockwave Medical, Inc., Sacramento , R&D Engineer II (Process Development), Engineering , Santa Clara, California