Design Lead

Design Lead

Design Lead | Others, IllinoisOthers, Rhode Island

Job Summary

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.

Compensation and Benefits

A candidate's pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.