Packaging Engineer - Urgent need

MillenniumSoft Inc; Franklin Lakes (NJ); On-site; USD 41,000 - 55,000; Full time

Job summary

MillenniumSoft Inc. is seeking a Mid-Level Packaging Engineer in Franklin Lakes, NJ for a 12-month contract on W2 to support sterile medical device packaging development and verification under the eCTW program.

The role requires expertise in designing robust packaging systems, leading tests, and collaborating across cross-functional teams to optimize packaging materials and processes. The candidate will apply first-principles engineering, statistical analysis, and Design Control to meet

Qualifications

• Bachelors/Master's/PhD in Mechanical Engineering or related field.
• Experience with sterile packaging design, ISO 11607/ASTM standards preferred.
• Strong data analysis and problem-solving skills; proficient in DOE and DoE.
• Familiarity with design controls and packaging validation activities.

Responsibilities

• Act as Packaging SME on cross-functional teams to drive packaging strategy.
• Develop and validate robust packaging concepts for sterile devices.
• Lead design verification, validation, and testing activities; generate protocols and reports.
• Collaborate with Manufacturing and Specimen Management on packaging designs and processes.
• Provide data-driven recommendations to leadership and drive improvements.

Skills

Packaging expertise

Cross-functional collaboration

Problem solving

Data analysis

Education

Bachelor's/Master's/PhD in Mechanical Engineering

Tools

Creo/SolidWorks

MS Office

Minitab

Job description

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

• 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.

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.