Senior, Packaging Design Engineer

Intuitive•Sunnyvale, CA

About The 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.

Requirements

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
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)

Responsibilities

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.
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.
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.