Packaging Engineer - Urgent Need

Role details

Position : Packaging Engineer Location : Franklin Lakes, NJ Duration : 12 Months Total Hours/week : 40.00

pay rate: $30-40/hr

1st Shift

Client : Medical Devices Company

Job Category : Engineering

Level of Experience : Mid-Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)7

Job Description

• The individual in this position will be 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.
• 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.
• Act 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 client organization to propose, assess the feasibility of, and implement packaging design/material/processes through rigorous Design Control processes.
• Independently determines and develops approach 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/or root-cause analysis to evaluate product packaging performance & improvements.
• Performs data analysis using statistical tools, generate reports and present 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 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 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 design & development of all levels of packaging with due consideration to safety, subsequent processing, environment & 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 required.
• Good written and verbal communication skills.
• Additional Job Description

Education

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