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Packaging Engineer
2 months ago
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.
- 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.
- Bachelors/Masters/PhD in Mechanical Engineering or related Engineering discipline.