Senior, Packaging Design Engineer

Primary Function of Position The Medical Device Packaging Design Engineer is a critical engineering role responsible for the design, development, verification, and launch of next-generation mechanical packaging systems for sterile and non-sterile medical devices such as surgical instruments, disposables, and electromechanical capital equipment. This individual will use sound engineering judgement and independently drive new product development (NPD) and sustaining engineering efforts through cross functional collaboration, ensuring designs meet stringent clinical, functional, global regulatory (FDA, ISO 11607, EU), and quality requirements. The successful candidate excels in a fast-paced environment, applying strong technical depth to resolve complex problems and ensure successful, compliant and scalable product launches. Essential Job Duties Design, Development, and Verification Lead the design, optimization, verification (including engineering testing) and documentation of complex primary, secondary, and tertiary mechanical packaging systems and components (e.g., trays, blisters, pouches, cartons, corrugated shippers, foam) for new product introductions (NPI) and existing products. Apply analytical skills and detailed engineering analysis (e.g., tolerance stack analysis, structural FEA, and process simulation) to ensure the fit, form, and function of complex packaging designs. Plan, execute, and document comprehensive packaging testing protocols (e.g., transit/distribution testing (ISTA/ASTM), seal strength, peel force, burst, leak) according to industry and regulatory standards. Rapidly develop and iterate full-scale prototypes of candidate designs that satisfy rigorous design requirements and user needs. Analyze and test components, including performing risk analyses and developing design requirements. Conduct advanced material evaluation and selection, interfacing with suppliers to qualify new packaging components and technologies for volume manufacturing. Represent Packaging Design Engineering on cross-functional project teams, leading the design and development of mechanical packaging systems for next-generation surgical and energy products. Work closely with Product Management, Human Factors and Clinical Development Engineering to translate clinical requirements and user needs into functional and technical specifications for packaging. Collaborate with manufacturing and automation teams to provide technical expertise to assist with the development of fixtures and assembly processes in as needed. Direct design changes, process improvements, and cost reductions aligned with regulatory, risk, and sustainability goals. Cross-functional Collaboration and Leadership Collaborate cross-functionally with Process Engineering, Quality Assurance, Manufacturing Operations, and Logistics teams to ensure seamless packaging integration and robust transfer to production. Interface with manufacturing to create product assembly and packaging tooling, fixtures, and instructions. Drive continuous improvement initiatives for packaging processes, materials, cost-effectiveness, and sustainability. Mentor junior engineers and provide technical guidance, inspiring the team toward successful project completion. Regulatory Compliance and Sustaining Support Ensure all designs and processes meet FDA, ISO 11607, and other global international standards, maintaining audit readiness for engineering functions. Support the quality and regulatory processes, which may include reviewing and approving submissions for packaging in regulatory filings (e.g., 510(k)). Provide mechanical engineering sustaining support for resolution of supply chain, manufacturing, and field issues for both the device and its packaging. Support production of the final product by troubleshooting process and component problems for mechanical packaging systems. Own packaging components and assemblies from concept through design verification, qualification, and commercial transfer. Perform root cause analysis and implement corrective/preventive actions (CAPA) for packaging design related non-conformances. Contribute to design processes, including Failure Modes and Effects Analyses (FMEA), to mitigate risks related to product damage and sterility. Required Skills and Experience Thorough working knowledge of packaging dynamics, various packaging materials and their compatibility with sterilization processes such as, but not limited to EtO, and Gamma. Knowledge of packaging validation and verification requirements under CFR Part 820, ISO11607 part 1 & 2 and applicable ASTM standards. Strong understanding of GMP. Strong design and project management skills and to manage multiple re-usable and/or single use disposable (SUD) packaging projects across multiple product lines, on time. Experience designing for thermoforming (FFS preferred), pouch sealing. Strong verbal and written communication skills required to successfully collaborate with cross-functional teams and effectively communicate at multiple levels in the organization. Demonstrate a high level of service while managing a high and varied workload from internal clients and adhering to tight timelines. Self-motivated with an ability to prioritize and multitask effectively in a fast-paced, dynamic environment. CAD knowledge and experience (Solidworks preferred). Must be able to travel occasionally to vendors, subcontractors and ISI Mexico plant Required Education and Training BS Packaging Engineering, Mechanical Engineering, Industrial Engineering or applicable technical field. 8+ years (or 6+ with Masters degree) of experience in medical device packaging design development for various packaging processes (high volume preferred) Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.