Staff Packaging Engineer: Surgical Robotics - OTTAVA

Job Title Staff Packaging Engineer – OTTAVA Location Santa Clara, California, United States of America 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. Key Responsibilities Technical Lead for 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 Minimum a Bachelor’s degree; preferred focused degree in Packaging Engineering, Mechanical Engineering, Materials Science, or related discipline. Advanced degree (Master’s) preferred. Experience Minimum six (6) years of relevant professional work experience. Hands‑on experience in capital large system packaging and in medical device industry. 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. 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 desirable. Experience in manufacturing/supply chain domains with cross‑functional collaboration. Additional Requirements May require up to 20% domestic and/or international travel. Fully onsite attendance required. Compensation Base salary range: $118,000.00 – $203,550.00. Equal Opportunity Employer Statement 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. Johnson & Johnson is committed to providing an inclusive interview process for applicants with disabilities and offers accommodations upon request. #J-18808-Ljbffr 6267-Auris Health Inc. Legal Entity