Packaging Engineer II

About This Role

This R&D Packaging Engineer II role focuses on developing, qualifying, and commercializing innovative packaging solutions for new and existing medical devices within the MDS business. The position involves applying engineering principles to design and verify packaging systems, conduct root cause analyses, and recommend strategic solutions to technical challenges, contributing to product excellence and regulatory compliance. This is a critical role for advancing healthcare.

Responsibilities

• Lead the design, development, and qualification of packaging systems for sterile and sterile fluid path medical devices, ensuring compliance with ISO 11607-1 & 2 and applicable regulatory standards.
• Be the owner of packaging specifications, responsible for the definition of all packaging system specifications.
• Collaborate in the design control process for medium and high complexity projects.
• Communicate data analysis including impact and recommended next steps to project/program leadership.
• Collaborate on complex projects impacting design inputs/outputs and verification through testing and analysis from start to finish.
• Ensure cross-functional strategies are clearly communicated and risks are appropriately managed.

Requirements

• Minimum of 1-4 years of experience in packaging engineering within the medical device or healthcare industry.
• Proven track record in designing and developing packaging systems for sterile and non-sterile medical devices, including compliance with ISO 11607-1 & 2 and other relevant standards.
• Demonstrated success collaborating with cross-functional projects involving new product development, sustaining engineering, and cost optimization initiatives.
• Proficiency in SolidWorks.

Qualifications

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field
• Minimum of 1-4 years of experience in packaging engineering within the medical device or healthcare industry.

Nice to Have

• Advanced degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field.
• Knowledge in Design for Six Sigma (DFSS).
• Basic statistical analysis skills.
• Design of Experiments (DOE) principles.
• Experience developing PFMEA and DFMEA.
• Knowledge of ISO 11607-1 & 2, ISO 13485, ISO 16975, and packaging-related ASTM or ISTA standards.
• Experience conducting gap assessments, ensuring alignment with FDA, EU MDR or other global packaging compliance requirements.
• Experience developing packaging technical rationales and design verification by analysis.
• Understanding and application of core engineering principles, including first-principles analysis and calculations, to address packaging design challenges and development activities.

Skills

* Required skills

Benefits