R&D Engineer II (Process Development)
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
- 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.
- Analyzes, evaluates, sources, and coordinates 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 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
- 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 - $115,000
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: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer