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Packaging Engineer

2 months ago

Franklin Lakes, United States Cynet Systems Full time
Job Description:

Pay Range: $41.42hr - $46.42hr
  • Works under general direction to guide design and development of sterile medical device packaging (e.g. sterile barrier systems) that are needed to meet the business' Enterprise Cost-To-Win (eCTW) objectives, covering a multitude of cost-savings and continuous improvement initiatives around device packaging and associated processes.
  • ct as Packaging subject matter expert on cross-functional teams to drive Packaging strategy and alignment to best practices and at times will function in a project leadership role.
  • Design/Engineer robust and manufacturable packaging by drawing on a combination of 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 the feasibility of, and implement packaging design/material/processes through rigorous Design Control processes.
  • Independently determines and develops approaches to solutions and presents results to peers and business leadership.
  • Drives creative, logic and risk-based approaches to resolve technical challenges and tradeoffs under business constraints including strong capacity for critical thinking and analysis.
  • 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.
  • Writes, implements, and leads hands-on benchtop studies, tolerance stack up analysis, design verification, validation, vendor interactions, material specifications, component specifications, troubleshooting and root-cause analysis to evvaluate product packaging performance & improvements.
  • Performs data analysis using statistical tools, generate reports and presents recommendations to peers and business leaders.
  • Provides inputs for manufacturing sites in process validation, process capability issues, and customer issues.
  • Supports 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.
  • Collects, records, reports, interprets, and analyzes data, presents results to peers and business leadership.
  • Provides advanced engineering skills and product packaging evaluation support to the platform towards building business cases for new opportunities.
  • Ensures compliance with 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 are essential requirements to be successful in this position.
  • Working knowledge of packaging industry standards and regulations, including.
  • Packaging Engineering Design (medical device sterile packaging design).
  • Packaging materials (flexible and rigid) & 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 are all strongly preferred.
  • Proficient in the design & development of all levels of packaging with due consideration to safety, subsequent processing, environment & shipment logistics.
  • Strong technical judgment 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.
  • bility to effectively and clearly communicate concepts, ideas, and knowledge to other individuals and teams.
  • Strong creative, analytical, and problem-solving skills required.
  • Good written and verbal communication skills.
Education:
  • Bachelors/Masters/PhD in Mechanical Engineering or related Engineering discipline.