Staff Packaging Engineer: Surgical Robotics – Ottava

Johnson & Johnson Johnson & Johnson · Pharma · Santa Clara, CA +1

Staff Packaging Engineer for Surgical Robotics (OTTAVA) at Johnson & Johnson, focusing on the design, development, testing, and validation of packaging systems for medical devices, including robotic capital equipment. The role requires ensuring product quality, regulatory compliance, manufacturability, and cost-effectiveness within a regulated medical device environment, collaborating with cross-functional teams and suppliers.

What you'd actually do

  1. Provide technical guidance and influence packaging strategy, standards and guidelines across projects.
  2. Design and develop primary, secondary, tertiary, and transport packaging for medical devices, accessories, and capital equipment.
  3. Execute packaging testing and validation activities per ASTM, ISTA, ISO, and internal procedures.
  4. Ensure packaging designs comply with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and applicable global packaging standards.
  5. Collaborate with R&D, Quality, Regulatory, Manufacturing, Procurement, and Logistics teams throughout development and launch.

Skills

Required

  • Packaging engineering
  • Capital large system experience
  • ASTM, ISTA, ISO, and global packaging test standards
  • Packaging validation
  • Distribution testing
  • Technical documentation
  • FDA QSR, ISO 13485, ISO 14971, and medical device quality systems
  • CAD tools (e.g., SolidWorks)
  • PLM systems for ECO management

Nice to have

  • Advanced degree (Master's)
  • Statistical methods (sampling plans, DOE)

What the JD emphasized

  • Packaging engineering with hands-on experience in capital large system
  • Working knowledge of ASTM, ISTA, ISO, and global packaging test standards.
  • Familiarity with FDA QSR, ISO 13485, ISO 14971, and medical device quality systems.