Principal R&D Engineer - Shockwave Medical

Johnson & Johnson Co.; Santa Clara (CA); On-site; USD 134,000 - 231,000; Full time

Job summary

Johnson & Johnson is hiring for a Principal R&D Engineer – Shockwave Medical to join our team located in Santa Clara, CA. We are advancing the next generation of intravascular lithotripsy devices to treat complex calcified cardiovascular disease.

The Principal R&D Engineer will provide technical leadership, design and test concepts, and collaborate with clinical and scientific teams to translate needs into new product designs while ensuring quality documentation and regulatory compliance.

Qualifications

• Bachelor’s Degree in Mechanical or Biomedical Engineering or a Master’s Degree with significant engineering experience.
• Experience in the medical device industry and disposable devices.
• Knowledge of peripheral and coronary device design, material selection, and testing.
• Strong CAD skills, especially SolidWorks, and ability to translate design into manufacturable products.

Responsibilities

• Provide technical leadership for projects and manage cross-functional teams.
• Design and develop products per Design Control and regulatory requirements.
• Prototype and test concepts; translate user needs into design solutions.
• Ensure documentation complies with the company quality system and regulatory standards.

Skills

SolidWorks CAD

Cross-functional leadership

Independent worker

Communication skills

Project management

Education

Bachelors in Mechanical or Biomedical Engineering

Masters in Engineering

Tools

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, 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 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.

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

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:

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

The anticipated base pay range for this position is :

$134,000.00 - $231,150.00

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 policies and date of hire, 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 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