J&J Family of Companies
Principal R&D Engineer - Shockwave Medical
J&J Family of Companies, Santa Clara, California, United States, 95050
Principal R&D Engineer
Shockwave Medical
Johnson & Johnson is hiring for a Principal R&D Engineer
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 will use technical and leadership skills in the development of innovative products to treat coronary and peripheral vascular disease with potential to expand to other vascular diseases. The Principal R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization, with a primary focus on early-stage / phase-zero development. This role will serve as technical lead for the early-stage development period of projects. Essential Job Functions Provide technical leadership for projects in the coronary and peripheral vascular space. Provide mentorship to other engineers and assignments to technicians as required. Collaborate cross-functionally to gather and define user needs for new products Prototype and develop proof of concept designs, disease models and test methods based on the defined user needs and requirements. Solve challenging and complex technical problems during the new product development process. 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. Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation. Develop protocols, test methods, and reports, and perform product assessments on benchtop, in-situ, and in-vivo to prove and de-risk viability and feasibility of new product designs. 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. Participate as SME on product development team(s) that manage projects from concept through transfer to PDP team. Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable regulatory requirements. Ensure proper documentation consistent with the company's quality system. Responsible for knowing and planning activities consistent with the company's quality policy and quality objectives. 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 in Mechanical or Biomedical (or similar) Engineering and 10 years' experience in engineering OR a Master's Degree and 8 years' experience in engineering OR a PhD and 6 years' experience in engineering. 3 years' experience in early-stage (pre-design freeze) catheter and/or leads-based cardiovascular device development, preferred. Knowledge of coronary and vascular anatomy, physiology, and model development is a strong plus. Minimum 1 year as team or project technical lead. Strong understanding of engineering materials, component selection, and design for reliability and manufacturability. Strong understanding of data analysis and statistics including design of experiments, Gage R&R, capability, etc. is a strong plus. Strong teamwork skills and demonstrated ability to work closely with cross functional partners. 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. Occasional travel up to 10% Employee may be required to lift objects up to 25 lbs. The anticipated base pay range for this position is: $141,000 - $227,700 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective plans, employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay, including Floating Holidays 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave
480 hours within one year of the birth/adoption/foster care of a child Condolence Leave
30 days for an immediate family member: 5 days for an extended family member Caregiver Leave
10 days Volunteer Leave
4 days Military Spouse Time-Off
80 hours
Shockwave Medical
Johnson & Johnson is hiring for a Principal R&D Engineer
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 will use technical and leadership skills in the development of innovative products to treat coronary and peripheral vascular disease with potential to expand to other vascular diseases. The Principal R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization, with a primary focus on early-stage / phase-zero development. This role will serve as technical lead for the early-stage development period of projects. Essential Job Functions Provide technical leadership for projects in the coronary and peripheral vascular space. Provide mentorship to other engineers and assignments to technicians as required. Collaborate cross-functionally to gather and define user needs for new products Prototype and develop proof of concept designs, disease models and test methods based on the defined user needs and requirements. Solve challenging and complex technical problems during the new product development process. 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. Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation. Develop protocols, test methods, and reports, and perform product assessments on benchtop, in-situ, and in-vivo to prove and de-risk viability and feasibility of new product designs. 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. Participate as SME on product development team(s) that manage projects from concept through transfer to PDP team. Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable regulatory requirements. Ensure proper documentation consistent with the company's quality system. Responsible for knowing and planning activities consistent with the company's quality policy and quality objectives. 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 in Mechanical or Biomedical (or similar) Engineering and 10 years' experience in engineering OR a Master's Degree and 8 years' experience in engineering OR a PhD and 6 years' experience in engineering. 3 years' experience in early-stage (pre-design freeze) catheter and/or leads-based cardiovascular device development, preferred. Knowledge of coronary and vascular anatomy, physiology, and model development is a strong plus. Minimum 1 year as team or project technical lead. Strong understanding of engineering materials, component selection, and design for reliability and manufacturability. Strong understanding of data analysis and statistics including design of experiments, Gage R&R, capability, etc. is a strong plus. Strong teamwork skills and demonstrated ability to work closely with cross functional partners. 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. Occasional travel up to 10% Employee may be required to lift objects up to 25 lbs. The anticipated base pay range for this position is: $141,000 - $227,700 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective plans, employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay, including Floating Holidays 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave
480 hours within one year of the birth/adoption/foster care of a child Condolence Leave
30 days for an immediate family member: 5 days for an extended family member Caregiver Leave
10 days Volunteer Leave
4 days Military Spouse Time-Off
80 hours