Sr. R&D Engineer (Clinical Engineering) - Shockwave

• Design and develop product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDD requirements
• Prototype and develop proof of concept designs, disease models and test methods of testing these concepts in a simulated environment and develop new product designs based on the defined user needs
• Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation
• Participate in 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 that lab notebooks are documented in a timely manner and consistent with the applicable SOP
• Develop protocols/reports and perform product in-vitro, in-vivo as well as 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
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products
• 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 5 years’ experience in engineering or a master’s degree with 3 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 highly preferred
• Strong foundation in basic science including engineering principles, anatomy, and physiology
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability highly preferred
• 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

• 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)).
• This position is eligible to participate in the Company’s long-term incentive program.
• 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.

Johnson & Johnson