Staff Packaging Engineer: Surgical Robotics – OTTAVA

Johnson & Johnson RAD (Robotics and Digital) is seeking for a Staff Packaging Engineer– OTTAVA, for our Santa Clara, Location.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/ (https://www.jnj.com/.

About MedTech Surgery 

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. 

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. 

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech 

Purpose:

The Staff Packaging Engineer supports the design, development, testing, and validation of packaging systems for medical devices, including robotic capital and durable medical equipment distributed globally. This role focuses on hands-on execution of packaging solutions within a regulated medical device environment, ensuring protection of product quality, regulatory compliance, manufacturability, and cost effectiveness. The position partners closely with R&D, quality, regulatory, manufacturing, service and repair, and delivery teams to support product development and commercialization.

Key Responsibilities

• Technical Lead for all phases of Packaging Design & Development

Provide technical guidance and influence packaging strategy, standards and guidelines across projects. Design and develop primary, secondary, tertiary, and transport packaging for medical devices, accessories, and capital equipment. Develop packaging specifications, drawings, and bills of materials. Support structural design, cushioning concepts, blocking and bracing, and material selection using corrugated, foam, plastics, wood, and steel-based solutions.

• Testing, Validation & Quality

Execute packaging testing and validation activities per ASTM, ISTA, ISO, and internal procedures. Support IQ/OQ/PQ execution, distribution simulation (drop, vibration, compression, shock), and accelerated aging studies (ASTM F1980). Ensure documentation is complete, accurate, and traceable within the DHF and DMR.

• Regulatory & Compliance

Ensure packaging designs comply with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and applicable global packaging standards. Support packaging-related content for regulatory submissions and participate in FDA or Notified Body audit activities as needed. Ensure compliance with labeling, UDI, ISPM 15, RoHS, and REACH requirements where applicable.

• Cross-Functional & Supplier Collaboration

Collaborate with R&D, Quality, Regulatory, Manufacturing, Procurement, and Logistics teams throughout development and launch. Support supplier qualification activities, packaging trials, and engineering change execution through PLM systems.

• Continuous Improvement & Sustainability

Support cost, quality, and sustainability initiatives including material optimization, waste reduction, logistics efficiency, and recycled content usage. Contribute to SOPs, work instructions, and continuous improvement efforts aligned with sustainability and PPWR objectives.

Qualifications:

Education: A minimum of a Bachelor’s degree and/or equivalent University degree is required; a focused degree in Packaging Engineering, Mechanical Engineering, Materials Science, or related engineering discipline is preferred. An advanced degree, Master’s is preferred.

Required:

• Minimum six (6) years of relevant professional work experience.
• Experience in Packaging engineering with hands-on experience in capital large system
• Working knowledge of ASTM, ISTA, ISO, and global packaging test standards. Experience executing packaging validation, distribution testing, and technical documentation.
• Familiarity with FDA QSR, ISO 13485, ISO 14971, and medical device quality systems.
• Proficiency with CAD tools (e.g., SolidWorks) and PLM systems for ECO management.
• Exposure to statistical methods such as sampling plans or basic DOE is desirable.

Preferred:

• Experience working in a regulated or medical device industry.
• Exposure to statistical methods such as sampling plans or basic DOE is desirable.
• Experience supporting capital or robotic medical equipment packaging.
• Knowledge of regulatory, sustainability requirements and standards for EU, Japan, Korea, and China (EPR)
• Exposure to regulatory submissions (FDA 510(k), PMA, or EU MDR Technical Files).
• Professional certifications such as CPP, RPT, ASQ, PMP, or Lean Six Sigma
• Experience in manufacturing/supply chain domains, with the ability to collaborate cross-functionally and drive adoption.

Other:

• May require up to 20% domestic and/or international travel (project dependent).
• The attendance policy required for this role is fully onsite