R&D Engineer II

Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the recent acquisition of Neovasc and their innovative Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. Together, we are working to bring these patients relief from their symptoms and hopefully improve their quality of life. Position Overview The R&D Engineer II must be located in Minnesota and must be able to commute to the New Brighton area on a daily basis. 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 companys 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 companys quality system Responsible for knowing and planning activities consistent the companys 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 Bachelors degree in Mechanical or Biomedical Engineering with 2 years experience in engineering or a masters 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: $83,200 – $104,000 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 Shockwave Medical Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.