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 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 - $115,000
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