Johnson & Johnson is hiring for a Sr. R&D Engineer, Systems – Shockwave Medical to join our team located in Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. 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 Sr. R&D Engineer, Systems will work with cross-functional teams to develop and sustain products at Shockwave Medical that satisfy customer needs and drive business strategies. The Sr. R&D Engineer, Systems will engage in specification writing and development; test and report writing and development; execute testing; DHF maintenance; and provide support to other departments as required. Essential Job Functions + Design and develop product(s) and documentation in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDD criteria + Participate on cross-functional development teams that manage projects from concept through commercialization + Evaluate existing document architecture and assess gaps and dependencies + Work with stakeholders to establish project needs and functional group interfaces. + Work with on-market groups and data sets to assess device performance. + Support sustaining activities for on-market products + Support quality audits and follow-up activities. + Ensure lab notebooks are documented in a timely manner and consistent with the applicable SOP + Develop protocols/reports and perform product in-vitro, in-vivo verification and validation testing + Good written and verbal communication skills to convey complex concepts and approaches Provide support to operations and regulatory initiatives as required. + Other duties as needed. **Qualifications** + Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or Electrical Engineering with 5+ years of medical device experience, or a Master’s degree in Biomedical Engineering, Mechanical Engineering, or Electrical Engineering with 3+ years of medical device experience. + Familiarity with Design History Files (DHF), Design Master Records (DMR), Traceability Matrices, and other outputs of the Product Development Process. + Familiarity with risk management processes and applications including FMEA, FTA and general risk analysis. + Working knowledge of cGDP, 820.30 and ISO 13485. + Ability to work in a fast-paced environment, managing multiple priorities. Experience with JAMA is a plus. + Employee may be required to lift objects up to 25lbs. Additional Information: + The anticipated base pay range for this position is $103,000 to $165,600 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.