Staff R&D Engineer

Johnson & Johnson Innovative Medicine•Irvine, CA

19h•Onsite

About The Position

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. 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. Johnson & Johnson MedTech, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff R&D Engineer, located in Irvine, CA. 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. The Staff 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.

Requirements

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.
Bachelor’s degree in Mechanical Engineering or a related engineering discipline
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 contributing effectively to cross-functional teams.

Nice To Haves

advanced degree preferred
Coaching
Contract Management
Critical Thinking
Design Thinking
Fact-Based Decision Making
Feasibility Studies
Incident Management
Mechanical Engineering
Organizing
Process Oriented
Product Development
Project Management Methodology (PMM)
Project Support
Research and Development
SAP Product Lifecycle Management
Technical Credibility
Technical Writing
Vendor Management

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.