Senior R&D Mechanical Engineer
About The Position
Johnson & Johnson MedTech, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior R&D Mechanical Engineer, located in Irvine, CA. About MedTech 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 https://www.jnj.com/medtech 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.
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 (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.
Nice To Haves
- advanced degree preferred
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.
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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
