Design Lead

Job Summary

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Key Responsibilities

• Owner of BDG's (Business Development Goals), responsible for developing and qualifying packaging solutions for aseptic and non-aseptic medical devices. Ensures alignment with domestic and international guidelines and standards.

• Leader of design control process of medium and high complexity projects. Owner of packaging systems specifications.

• Able to lead complex projects impacting design inputs / outputs, verification by testing / analysis, from start to end. Ensures appropriate multi-functional strategy is in place and manages risks appropriately to ensure compliance to specifications and timeline.

• Translate customer needs into engineering requirements leading to specific packaging and process specifications

• Represent the R&D Packaging Function on multi-functional teams in order to drive Packaging strategy

• Demonstrate strong personal accountability for successful completion of designate specific tasks and/or complete projects.

• Effectively communicate and influence decisions among project teams as well as functional and business leadership reviews

• Proactively develop, maintain & share technical knowledge in specialized area(s), remaining up to date on current trends and company policies. Mentor junior members in the organization

Skill Requirements

• Bachelor’s degree in Packaging, Mechanical, Biomedical Engineering or a related technical field, with equivalent experience also considered; advanced degree preferred.

• Minimum of 5–8 years of experience in packaging engineering within the medical device or drug development industries.

• Proven track record developing different packaging design systems for sterile medical device and/or pharmaceutical products. Demonstrated understanding to ISO 11607-1 & 2, ISO 13485, ISO 16975, ICH Guidelines, and packaging-related ASTM or ISTA standards.

• Demonstrated expertise in Design for Six Sigma (DFSS), statistical analysis, and Design of Experiments methodologies.

• Proven ability to define and document packaging requirements for sterile packaging solutions. Proficient designing different packaging systems types for medical devices and pharmaceutical products.

• Experience with packaging design software ex. CAPE or TOPS and Solidworks.

• Skilled in verification and validation of content sterile packaging systems, ensuring compliance with regulatory standards. Experienced developing Packaging PFMEA and DFMEA.

• Proven experience developing technical rationales and design verification by analysis for pharmaceutical and/or medical device closure systems.

• Experience performing FEA to evaluate and optimize packaging designs.

• Understanding and application of core engineering principles, including first-principles analysis and calculations, to address packaging design challenges and development activities.

Other Requirements

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