Senior R&D Mechanical Engineer
$109,000–$174,800 year
On-site · Irvine, California, United States
Job Summary
Senior R&D Mechanical Engineer responsible for delivering engineering expertise across the product lifecycle for regulated medical devices, with emphasis on catheter-based technologies. Lead and contribute to device design and development activities, support Design Verification Testing (DVT) and Verification & Validation (V&V) to ensure regulatory compliance, collaborate with Manufacturing, Quality, Regulatory, and Clinical teams to enable design for manufacturability and smooth product transfer, and mentor junior engineers while applying Johnson & Johnson’s Credo and Leadership Imperatives.
Required Qualifications
- Bachelor’s degree in Mechanical Engineering or a related engineering discipline
- Hands-on experience with catheter design and development
- Experience supporting products through DVT and V&V in a regulated environment
- Experience working on Class II and/or Class III medical devices
- Strong mechanical design, device development, and/or manufacturing engineering background
- Working knowledge of design controls, risk management, and regulatory requirements for medical devices
- Ability to work independently while contributing to cross-functional teams
Desired Qualifications
- Bachelor’s degree in Mechanical Engineering or related engineering discipline
- Experience with catheter design and development
- Experience with Design Verification Testing (DVT) and Verification & Validation (V&V) in a regulated environment
- Knowledge of design controls, risk management, and regulatory requirements for medical devices
- Strong analytical, problem-solving, and technical documentation skills
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