Johnson & Johnson
Sr. R&D Engineer (Clinical Engineering) - Shockwave
Johnson & Johnson, Santa Clara, California, us, 95053
Overview
Johnson & Johnson is hiring for a Sr R&D Engineer (Clinical Engineering) – Shockwave Medical to join our team in Santa Clara, CA. We develop the next generation of smarter, less invasive, more personalized treatments and are pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Fueled by innovation at the intersection of biology and technology, we aim 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 (Clinical Engineering) will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The engineer will participate in multiple cross-functional development teams that manage projects from concept through commercialization. Responsibilities
Design and develop products 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 testing methods in a simulated environment; develop new product designs based on defined user needs. Analyze, evaluate, source, and coordinate procurement of new materials to support prototyping and pilot operations. Participate in cross-functional development teams that manage projects from concept through commercialization. Ensure proper documentation consistent with the company’s quality system; maintain lab notebooks timely and per applicable SOPs. Plan activities aligned with the company’s quality policy and quality objectives. Develop protocols/reports and perform product in-vitro and in-vivo testing as well as verification and validation testing. Perform process-related design tasks to support pilot manufacturing. Identify suppliers and manage relationships to ensure delivery of high-quality components and services. Maintain current knowledge of competitive technologies and related medical/biomedical developments. Document component and assembly data for new products; support quality systems and FDA regulatory requirements. Other duties as assigned. Qualifications
Bachelor’s degree in Mechanical or Biomedical Engineering with 5 years’ engineering experience, or a master’s degree with 3 years’ experience. Engineering experience in the medical device industry is highly preferred. Knowledge of disposable peripheral and coronary device design, material selection, and testing is highly preferred. Strong foundation in basic science, engineering principles, anatomy, and physiology. Understanding of engineering materials, component selection, and design for reliability and manufacturability is highly preferred. Experience in early-stage catheter-based cardiovascular device development is a strong plus. Effective communication skills with all levels of management; ability to work in a fast-paced environment and manage multiple priorities. Ability to work in a team or independently with flexibility to changing requirements. Employee may be required to lift objects up to 25 lbs. Additional Information
The anticipated salary range for this position is $103,000 - $165,600. The Company maintains highly competitive, performance-based compensation programs. Eligible for an annual performance bonus as applicable; bonuses are discretionary. Employee benefits may include medical, dental, vision, life insurance, disability coverages, and group legal insurance. Retirement plan options (pension and 401(k)) and eligibility for long-term incentive programs. Paid time off: Vacation up to 120 hours/year; Sick time up to 40 hours/year (Washington residents up to 56 hours); Holidays up to 13 days/year; Personal/Family time up to 40 hours/year. Additional information can be found at the provided company benefits link. The compensation and benefits information applies to candidates in the United States; varies by location for other regions. EEO Statement:
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 employee wellness and career support, please visit www.careers.jnj.com.
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Johnson & Johnson is hiring for a Sr R&D Engineer (Clinical Engineering) – Shockwave Medical to join our team in Santa Clara, CA. We develop the next generation of smarter, less invasive, more personalized treatments and are pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Fueled by innovation at the intersection of biology and technology, we aim 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 (Clinical Engineering) will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The engineer will participate in multiple cross-functional development teams that manage projects from concept through commercialization. Responsibilities
Design and develop products 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 testing methods in a simulated environment; develop new product designs based on defined user needs. Analyze, evaluate, source, and coordinate procurement of new materials to support prototyping and pilot operations. Participate in cross-functional development teams that manage projects from concept through commercialization. Ensure proper documentation consistent with the company’s quality system; maintain lab notebooks timely and per applicable SOPs. Plan activities aligned with the company’s quality policy and quality objectives. Develop protocols/reports and perform product in-vitro and in-vivo testing as well as verification and validation testing. Perform process-related design tasks to support pilot manufacturing. Identify suppliers and manage relationships to ensure delivery of high-quality components and services. Maintain current knowledge of competitive technologies and related medical/biomedical developments. Document component and assembly data for new products; support quality systems and FDA regulatory requirements. Other duties as assigned. Qualifications
Bachelor’s degree in Mechanical or Biomedical Engineering with 5 years’ engineering experience, or a master’s degree with 3 years’ experience. Engineering experience in the medical device industry is highly preferred. Knowledge of disposable peripheral and coronary device design, material selection, and testing is highly preferred. Strong foundation in basic science, engineering principles, anatomy, and physiology. Understanding of engineering materials, component selection, and design for reliability and manufacturability is highly preferred. Experience in early-stage catheter-based cardiovascular device development is a strong plus. Effective communication skills with all levels of management; ability to work in a fast-paced environment and manage multiple priorities. Ability to work in a team or independently with flexibility to changing requirements. Employee may be required to lift objects up to 25 lbs. Additional Information
The anticipated salary range for this position is $103,000 - $165,600. The Company maintains highly competitive, performance-based compensation programs. Eligible for an annual performance bonus as applicable; bonuses are discretionary. Employee benefits may include medical, dental, vision, life insurance, disability coverages, and group legal insurance. Retirement plan options (pension and 401(k)) and eligibility for long-term incentive programs. Paid time off: Vacation up to 120 hours/year; Sick time up to 40 hours/year (Washington residents up to 56 hours); Holidays up to 13 days/year; Personal/Family time up to 40 hours/year. Additional information can be found at the provided company benefits link. The compensation and benefits information applies to candidates in the United States; varies by location for other regions. EEO Statement:
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 employee wellness and career support, please visit www.careers.jnj.com.
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