Senior R&D Mechanical Engineer

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 Med Tech, 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  

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:*
* R&D Mechanical Engineering

** Job Category:*
* Scientific/Technology

** All Job Posting Locations:*
* Irvine, California, United States of America

*
* Job Description:

*
* Johnson & Johnson Med Tech, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a  
** Senior R&D Mechanical Engineer** , located in  
** Irvine, CA** .

** About Med Tech*
* Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, and more personalized treatments. Your unique talents will help patients on their journey to wellness.

Learn more at

** Overview*
* The Senior R&D Mechanical Engineer is a seasoned individual contributor responsible for delivering engineering expertise across all stages of the product lifecycle. This role applies advanced engineering principles to support  
** device design, development, verification, validation, and manufacturing transfer
** of regulated medical devices, with a strong focus on  
** catheter-based technologies** . The role partners closely with cross‑functional teams to deliver safe, effective, and compliant products to market.

** Key Responsibilities*
* + Provide advanced mechanical engineering support throughout  
** design, development, verification, validation, and commercialization
** of medical devices.

+ Lead and contribute to  
** device design and development activities** , including component and system-level design.

+ Support and review  
** Design Verification Testing (DVT)
** and  
** Verification & Validation (V&V)
** activities to ensure compliance with regulatory and product requirements.

+ Apply proven scientific and engineering methodologies to develop high-quality, innovative products.

+ Collaborate closely with Manufacturing, Quality, Regulatory, and Clinical partners to support  
** design for manufacturability
** and smooth product transfer.

+ Investigate, document, and resolve reported incidents to maintain product quality and reliability.

+ Prepare and review technical documentation, reports, test protocols, and design history file content.

+ Develop proposals for new R&D initiatives in support of capital expenditure planning.

+ Coach and mentor junior engineers in methods, tools, and best practices.

+ Demonstrate and apply Johnson & Johnson's Credo and Leadership Imperatives in daily work.

** Required &

Preferred Experience *
* +  
** Hands-on experience in catheter design and development** , including component or system-level ownership.

+ Experience supporting products through  
** DVT and V&V phases
** in a regulated environment.

+ Experience working on  
** Class II and/or Class III medical devices** .

+ Strong background in  
** mechanical design, device development, and/or manufacturing engineering** .

+ Experience partnering with Manufacturing or Operations teams to ensure robust, scalable designs.

+ Working knowledge of design controls, risk management, and regulatory requirements for medical devices.

** Qualifications*
* + Bachelor's degree in Mechanical Engineering or a related engineering discipline (advanced degree preferred).

+ Proven experience in mechanical engineering within a medical device R&D environment.

+ Strong analytical, problem-solving, and technical documentation skills.

+ Ability to work independently while…