Principal R&D Engineer - Shockwave Medical

jj; Santa Clara (CA); On-site; USD 134,000 - 231,000; Full time

Benefits offered by this job

Vacation – 120 hours per year

Sick time – 40 hours per year

Parental Leave – 480 hours per year

401(k) retirement plan

Job summary

Johnson & Johnson is hiring a Principal R&D Engineer – Shockwave Medical for our Santa Clara, CA team. You will lead multi-disciplinary efforts to develop next‑generation intravascular lithotripsy devices and related cardiovascular technologies.

You will collaborate with clinical and scientific experts to translate clinical needs into robust design solutions, supervise teams, and ensure rigorous documentation and quality compliance throughout the product lifecycle.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering with 10 years of engineering experience or Master’s with 8 years.
• Experience in the medical device industry.
• Experience developing disposable medical devices.
• Knowledge of disposable peripheral and coronary device design, material selection, and testing.
• Strong hands-on experience with CAD software like SolidWorks.

Responsibilities

• Provide technical leadership for projects including managing technology development teams.
• Manage resources and timelines for development programs.
• Design and develop products in compliance with Design Control and regulatory requirements.
• Prototype and test concept designs and develop new product designs from user needs.
• Collaborate with clinical/scientific advisors and KOLs to translate clinical needs into design solutions.
• Ensure proper documentation per the quality system and company policies.

Skills

Mechanical/Biomedical engineering

CAD (SolidWorks)

Regulatory compliance

Cross-functional leadership

Prototyping and testing

Documentation

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Master’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

CAD software

Job description

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, andsolutions 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Principal R&D Engineer – 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/.

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 skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Principal R&D Engineer will 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 in Mechanical or Biomedical Engineering and 10 years’ experience in engineering OR a Master’s Degree and 8 years’ experience in engineering.
• Engineering experience in the medical device industry.
• Experience developing disposable medical devices.
• Knowledge of disposable peripheral and coronary device design, material selection, and testing.
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
• Experience in early-stage catheter based cardiovascular devices development is a strong plus.
• Strong hands‑on experience with CAD software like Solidworks.
• 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.
• Previous experience managing cross functional teams is preferred.
• 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.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills:

• Bioinformatics
• Biological Engineering
• Biostatistics
• Clinical Trials Operations
• Coaching
• Communication
• Critical Thinking
• Global Market
• Healthcare Trends
• Medical Affairs
• Organizing
• Product Development
• Project Reporting
• Research and Development
• Researching
• Resource Planning
• SAP Product Lifecycle Management

Preferred Skills:

• Bioinformatics
• Biological Engineering
• Biostatistics
• Clinical Trials Operations
• Coaching
• Communication
• Critical Thinking
• Global Market
• Healthcare Trends
• Medical Affairs
• Organizing
• Product Development
• Project Reporting
• Research and Development
• Researching
• Resource Planning
• SAP Product Lifecycle Management

Base Pay Range:

$134,000.00 - $231,150.00

Additional Description for Pay Transparency:

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)).

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits