J&J Family of Companies
Prin. R&D Engineer (Reducer Catheter)
J&J Family of Companies, Santa Clara, California, United States, 95050
Principal R&D Engineer (Reducer Catheter)
Shockwave Medical
Johnson & Johnson is hiring for a Principal R&D Engineer (Reducer Catheter)
Shockwave Medical to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio 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 Principal R&D Engineer (Reducer catheter) will use technical skills in the development of innovative products to treat coronary artery disease and angina. The Principal R&D Engineer will lead and participate on multiple cross-functional development teams that manage projects from concept through commercialization. Essential Job Functions Provide technical leadership for projects including managing technology development teams Responsible for managing technology and other relevant resources. Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable regulatory 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. Work with clinical and scientific advisors as well as Key Opinion Leaders in translating clinical needs into design solutions while utilizing these resources to develop and optimize product design. Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation. Participate as SME or core team member on product development team(s) 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 the company's quality policy and quality objectives. 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 as necessary. Identify suppliers and maintain relationships to ensure the delivery of superior components and services. Enhance the intellectual property position of the company via invention disclosures and patent applications. 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. Requirements Bachelor's Degree (Master's or PhD preferred) in Mechanical, Biomedical Engineering, or equivalent experience. Minimum of 10 years' experience in engineering preferably in the medical device industry. 3+ years of experience in leading cross-functional technical teams 3+ years of experience in representing R&D on a cross-functional core team Expertise and experience in developing balloon catheters, catheters, access/delivery systems Experience developing disposable medical devices. Strong understanding of engineering materials, component selection, and design for reliability and manufacturability. Effective communication skills with all levels of management and organizations. Operate independently and adaptability to changing requirements. Ability to work in a fast-paced environment, managing multiple priorities. Employee may be required to lift objects up to 25lbs. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. The anticipated base pay range for this position is: $115,000-$197,800
Shockwave Medical
Johnson & Johnson is hiring for a Principal R&D Engineer (Reducer Catheter)
Shockwave Medical to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio 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 Principal R&D Engineer (Reducer catheter) will use technical skills in the development of innovative products to treat coronary artery disease and angina. The Principal R&D Engineer will lead and participate on multiple cross-functional development teams that manage projects from concept through commercialization. Essential Job Functions Provide technical leadership for projects including managing technology development teams Responsible for managing technology and other relevant resources. Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable regulatory 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. Work with clinical and scientific advisors as well as Key Opinion Leaders in translating clinical needs into design solutions while utilizing these resources to develop and optimize product design. Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation. Participate as SME or core team member on product development team(s) 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 the company's quality policy and quality objectives. 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 as necessary. Identify suppliers and maintain relationships to ensure the delivery of superior components and services. Enhance the intellectual property position of the company via invention disclosures and patent applications. 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. Requirements Bachelor's Degree (Master's or PhD preferred) in Mechanical, Biomedical Engineering, or equivalent experience. Minimum of 10 years' experience in engineering preferably in the medical device industry. 3+ years of experience in leading cross-functional technical teams 3+ years of experience in representing R&D on a cross-functional core team Expertise and experience in developing balloon catheters, catheters, access/delivery systems Experience developing disposable medical devices. Strong understanding of engineering materials, component selection, and design for reliability and manufacturability. Effective communication skills with all levels of management and organizations. Operate independently and adaptability to changing requirements. Ability to work in a fast-paced environment, managing multiple priorities. Employee may be required to lift objects up to 25lbs. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. The anticipated base pay range for this position is: $115,000-$197,800