Senior, Packaging Design Engineer

Job Overview

The Medical Device Packaging Design Engineer leads 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. The role ensures designs meet clinical, functional, and regulatory (FDA, ISO 11607, EU) requirements while driving new product development and sustaining engineering in a fast‑paced environment.

• Lead design, optimization, verification, and documentation of 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 tolerance stack analysis, structural FEA, and process simulation to ensure fit, form, and function of complex packaging designs.
• Plan, execute, and document comprehensive packaging testing protocols (transit/distribution testing, seal strength, peel force, burst, leak) according to industry and regulatory standards.
• Develop and iterate full‑scale prototypes, perform risk analyses, and develop design requirements.
• Conduct advanced material evaluation and selection; qualify new packaging components and technologies for volume manufacturing.
• Represent Packaging Design Engineering on cross‑functional project teams and collaborate with Product Management, Human Factors and Clinical Development Engineering to translate clinical requirements into functional specifications.
• Collaborate with manufacturing and automation teams to provide technical expertise for fixture and assembly process development.
• Direct design changes, process improvements, and cost reductions aligned with regulatory, risk, and sustainability goals.
• Collaborate with Process Engineering, Quality Assurance, Manufacturing Operations, and Logistics to integrate packaging into production and ensure seamless transfer to manufacturing.
• Interface with manufacturing to create product assembly, packaging tooling, fixtures, and instructions.
• Drive continuous improvement initiatives for packaging processes, materials, cost‑effectiveness, and sustainability.
• Mentor junior engineers and provide technical guidance to the team.
• Ensure all designs and processes meet FDA, ISO 11607, and other global standards; maintain audit readiness for engineering functions.
• Review and approve submissions for packaging in regulatory filings (e.g., 510(k)).
• Provide mechanical engineering sustaining support for supply chain, manufacturing, and field issues related to packaging.
• Support production troubleshooting for mechanical packaging systems.
• Own packaging components and assemblies from concept through design verification, qualification, and commercial transfer.
• Perform root cause analysis and implement CAPA for packaging design non‑conformances.
• Contribute to FMEA and other design processes to mitigate risks related to product damage and sterility.

• Thorough knowledge of packaging dynamics, materials, and compatibility with sterilization processes (e.g., EtO, Gamma).
• Understanding of CFR Part 820, ISO 11607 parts 1 & 2, ASTM standards, and GMP.
• Strong design and project management skills; ability to manage multiple reusable and/or single‑use disposable packaging projects across product lines on time.
• Experience designing for thermoforming (FFS preferred) and pouch sealing.
• Strong verbal and written communication skills for collaboration with cross‑functional teams.
• High level of service orientation while managing a varied workload and tight timelines.
• Self‑motivated, prioritizing and multitasking effectively in a dynamic environment.
• CAD knowledge and experience (Solid Works preferred).
• Willingness to travel occasionally to vendors, subcontractors, and ISI Mexico plant.

• BS in Packaging Engineering, Mechanical Engineering, Industrial Engineering, or applicable technical field.
• 8+ years (or 6+ with a master’s degree) of experience in medical device packaging design and development for high‑volume processes.

• Proof of vaccination against certain diseases, including COVID‑19, may be required.
• U.S. export controls may apply; final offers contingent on export license or TCP.
• Equal Opportunity
  
  Employer:
  
  discrimination and harassment of any type are prohibited.
• Qualified applicants with criminal records will be considered in accordance with fair chance laws.
• Preference will be given to candidates who do not reside in specified states.
• The position may be filled at a different job level based on business need and candidate experience.

Base Compensation Range Region 1: $162,800 – $234,200 USD
Base Compensation Range Region 2: $138,400 – $199,100 USD

Shift: Day
Workplace Type:
Set Schedule – onsite weekly, with the percentage of onsite work defined by the leader.