Packaging Engineer - Urgent need

About the role

This position will serve as a Packaging subject matter expert (SME) to provide support for design, development, verification, and validation of sterile medical device packaging (e.g., sterile barrier systems) under the Enterprise Cost-To-Win (eCTW) Program for the client Specimen Management business.

Responsibilities

• Guide design and development of sterile medical device packaging needed to meet business eCTW objectives, covering cost-savings and continuous improvement initiatives around device packaging and associated processes
• Act as Packaging SME on cross functional teams to drive Packaging strategy and alignment to best practices; at times function in a project leadership role
• Design/engineer robust and manufacturable packaging using experience, sound judgment, problem-solving skills, engineering first principles, advanced engineering methods and critical thinking
• Collaborate with Manufacturing and other associates across Specimen Management and the wider organization to propose, assess feasibility of, and implement packaging design/material/processes through rigorous Design Control processes
• Independently determine and develop approach to solutions; present results to peers and business leadership
• Drive creative, logic and risk-based approaches to resolve technical challenges and tradeoffs under business constraints
• Develop, write, and execute robust packaging test methods, test fixtures, measurement systems analysis, protocols, data analysis and reports for Engineering studies, Design Verification, Validation, material and component specifications
• Write, implement, and lead hands-on benchtop studies, tolerance stack up analysis, design verification, validation, vendor interactions, material specifications, component specifications, troubleshooting and/or root-cause analysis to evaluate product packaging performance and improvements
• Perform data analysis using statistical tools; generate reports and present recommendations to peers and business leaders
• Provide inputs for manufacturing sites in process validation, process capability issues, and customer issues
• Support and at times lead material, packaging design and/or process changes to existing products by following design control process and generating well-documented research and analyses records
• Demonstrate strong drive for results and clear accountability for successful and timely completion of designated tasks and projects
• Collect, record, report, interpret, and analyze data; present results to peers and business leadership
• Provide advanced engineering skills and product packaging evaluation support to the platform towards building business cases for new opportunities
• Ensure compliance with client quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles

Qualifications

• Strength in scientific and engineering fundamentals based on first principles understanding including critical thinking and systematic problem-solving skills as well as business acumen and learning agility
• Working knowledge of packaging industry standards and regulations, including: Packaging Engineering Design (medical device sterile packaging design), Packaging materials (flexible and rigid) and sterilization processes, Packaging Testing methods, Labeling Testing methods (PTS), High volume regulated manufacturing, ISO-11607/ASTM D4169, ISO 13485/21 CFR Part 820
• Experience with forming/sealing process and tooling for hard and soft blister packs, web materials made of thermoplastics and reinforced paper, shrink wraps, flow wraps, automatic case carton erection, labeling (materials, adhesives, inks/printing, etc.), UDI compliance and barcode printing/decoding (all strongly preferred)
• Proficient in design and development of all levels of packaging with due consideration to safety, subsequent processing, environment and shipment logistics
• Strong technical judgement and leadership skills
• Product development considerations for tightly controlled high-volume manufacturing process
• Disciplined in phase-gate product development and project planning
• Strong project management, prioritizing, and multi-tasking skills to work within tight deadlines
• Understanding of Measurement Systems Analysis (MSA)
• Proficiency with statistical methods including DoE and data analysis using software such as Minitab
• Proficiency in solid CAD modeling (Creo, SolidWorks or equivalent) and design for manufacturability including injection molded and related systems and assemblies
• Proficiency with fixture design including basic machining considerations and developing test methods (fixture design and hands-on testing)
• Proficiency with TOPS (or similar pallet configuration tool) is a plus
• Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies
• R&D functional planning, requirement generation and technical (DFSS/Design/Cross functional) reviews for all product development phases
• Proficiency with any of FEA and/or CFD modeling software is a plus
• Certified Packaging Professional through the Institute of Packaging Professionals is strongly preferred
• Ability to effectively and clearly communicate concepts, ideas, and knowledge to other individuals and teams
• Strong creative, analytical, and problem-solving skills
• Good written and verbal communication skills

Education

Bachelors/Masters/PhD in Mechanical Engineering or related Engineering discipline.