Senior R&d Mechanical Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Irvine, CA +1

Senior R&D Mechanical Engineer responsible for delivering engineering expertise across all stages of the product lifecycle for regulated medical devices, with a strong focus on catheter-based technologies. This role involves device design, development, verification, validation, and manufacturing transfer, partnering with cross-functional teams to deliver safe, effective, and compliant products to market.

What you'd actually do

  1. Provide advanced mechanical engineering support throughout design, development, verification, validation, and commercialization of medical devices.
  2. Lead and contribute to device design and development activities, including component and system-level design.
  3. Support and review Design Verification Testing (DVT) and Verification & Validation (V&V) activities to ensure compliance with regulatory and product requirements.
  4. Apply proven scientific and engineering methodologies to develop high-quality, innovative products.
  5. Collaborate closely with Manufacturing, Quality, Regulatory, and Clinical partners to support design for manufacturability and smooth product transfer.

Skills

Required

  • 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 have

  • Business Case Modeling
  • Coaching
  • Critical Thinking
  • Design Thinking
  • Feasibility Studies
  • Mechanical Engineering
  • Problem Solving
  • Process Oriented
  • Product Design
  • Product Development
  • Project Management Methodology (PMM)
  • Project Support
  • Research and Development
  • SAP Product Lifecycle Management
  • Technical Credibility
  • Technical Writing
  • Technologically Savvy
  • advanced degree preferred

What the JD emphasized

  • catheter design and development
  • DVT and V&V phases
  • Class II and/or Class III medical devices
  • mechanical design, device development, and/or manufacturing engineering
  • design controls, risk management, and regulatory requirements for medical devices