R&D Engineer II

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 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.

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Johnson & Johnson MedTech a member of Johnson & Johnsons Family of Companies is currently recruiting for a R&D Engineer II located in Irvine CA.

About MedTech

Fueled by innovation at the intersection of biology and technology were 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 R&D Engineer II 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 crossfunctional 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 & Johnsons 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

• Bachelors 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 contributing effectively to cross-functional teams.

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 law.

Johnson & Johnson is committed to providing an inclusive interview process. If you require an accommodation please contact the Employee Health Support Center or AskGS for assistance.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment as well as get a parents consent for the background check.

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