Staff Packaging Engineer: Surgical Robotics - OTTAVA

Job Description Johnson & Johnson RAD (Robotics and Digital) seeks a Staff Packaging Engineer – OTTAVA for the Santa Clara, California location. 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. Other May require up to 20% domestic and/or international travel (project dependent). The attendance policy required for this role is fully onsite. 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 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. Required Skills Coaching, Competitive Landscape Analysis, Critical Thinking, EHS Compliance, Engineering, Good Manufacturing Practices (GMP), Lean Supply Chain Management, Organizing, Package and Labeling Regulations, Package Management, Process Improvements, Product Packaging Design, Science, Technology, Engineering, and Math (STEM) Application, Standard Operating Procedure (SOP), Sustainability, Sustainable Packaging, Transparency Reporting, Validation Testing. Preferred Skills Coaching, Competitive Landscape Analysis, Critical Thinking, EHS Compliance, Engineering, Good Manufacturing Practices (GMP), Lean Supply Chain Management, Organizing, Package and Labeling Regulations, Package Management, Process Improvements, Product Packaging Design, Science, Technology, Engineering, and Math (STEM) Application, Standard Operating Procedure (SOP), Sustainability, Sustainable Packaging, Transparency Reporting, Validation Testing. Salary and Benefits Anticipated base pay range: $118,000.00 – $203,550.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Benefits: Vacation – 120 hours per calendar year. Sick time – 40 hours per calendar year; for employees who reside in Colorado – 48 hours per calendar year; for employees who reside in 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. For additional general information on Company benefits, please visit Equal Opportunity Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. #J-18808-Ljbffr Dormont Manufacturing Co