Staff R&D Engineer (Model & Claims Development) - Shockwave Medical

At Johnson & Johnson, we all belong.

Shockwave Medical, Inc., recently acquired by Johnson & Johnson, 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.

Position Overview

The Staff R&D Engineer (Model and Claims Development) will use technical skills in the evaluation and testing of innovative products as well as the development of clinically relevant models for peripheral, coronary, and heart valve diseases. The Staff R&D Engineer will work closely with marketing and regulatory to design bench tests, model designs, and test plans drive the development of marketing claims to support business requirements. He or she will work closely with marketing to interface with customers to ensure the tests and models meet physician requirements. This Staff R&D Engineer will be expected to become the resident expert on competitive and complementary technology.

Essential Job Functions

• Evaluate and test Shockwave devices to support development of marketing claims

• Test on market or soon to be launched products

• Develop or improve disease models and test methods of testing these concepts in a simulated environment

• Support a long-term strategy with Technologies Development Team for evaluating new models and test methods for next-generation catheter concepts

• Participate in cross-functional development team that develops products from Phase II through the full market launch

• 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

• Support the development of protocols/reports and product testing in in-vitro and pre-clinical models, as necessary for claims development

• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company's products

• Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations

• Other duties as assigned

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering with 8 years' experience in engineering or a master's degree with 6 years' experience in engineering
• Engineering experience in the medical device industry is highly preferred
• 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
• 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, 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
• Travel up to 20%

Additional Information:

• The anticipated base pay range for this position is $121,000 to $194,350 annually.
• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.