Principal R&D Engineer - Shockwave Medical

FAMU National Alumni Association

Santa Clara (CA)

On-site

USD 134,000 - 231,000

Full time

11 hours ago

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Job summary

Johnson & Johnson is hiring a Principal R&D Engineer - Shockwave Medical for its Santa Clara, CA team. You will lead cross-functional development from concept to commercialization, driving innovative, less invasive, and personalized cardiovascular solutions using sonic pressure waves.

Strong collaboration with clinicians and engineers is essential. The role emphasizes leadership, regulatory compliance, and robust design verification across in vitro and in vivo studies, with opportunities to

Qualifications

Bachelor's degree in Mechanical or Biomedical Engineering with 10 years' engineering experience
Experience in the medical device industry
Experience developing disposable medical devices
Knowledge of peripheral and coronary device design, materials, and testing
Hands-on CAD experience with SolidWorks
Ability to lead cross-functional teams and manage multiple priorities

Responsibilities

Provide technical leadership for projects and manage technology development teams
Design and develop products in compliance with design control and regulatory requirements
Prototype and validate concepts and develop new product designs from user needs
Collaborate with clinicians and KOLs to translate clinical needs into design solutions
Source and coordinate procurement of materials for prototyping and pilot operation
Serve as SME on product development teams from concept to commercialization
Ensure documentation aligns with the quality system
Support quality policy and quality objectives and regulatory compliance
Develop protocols and perform in-vitro and in-vivo testing
Assist with pilot manufacturing processes as needed
Identify suppliers and maintain relationships for components and services
Contribute to IP through disclosures and patent applications
Maintain knowledge of competitive technologies and medical developments
Prepare component and assembly documentation for new products

Skills

Communication

Leadership

Cross-functional collaboration

Independence

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Job description

The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.

Principal R&D Engineer - Shockwave Medical

The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.

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

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.

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

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)).

This position is eligible to participate in the Company's long-term incentive program.

Benefits

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