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ApTask · 2 months ago

MDR - Packaging Engineer

New Haven, CT

Full-time

Onsite

Mid, Senior Level

$65K/yr - $70K/yr

2+ years exp

ApTask is a leading global provider of workforce solutions and talent acquisition services. They are seeking a Packaging Engineer to manage OEM Packaging opportunities for medical devices, focusing on design, development, and testing of packaging solutions.

Human ResourcesInformation TechnologySmall and Medium BusinessesStaffing Agency

Growth Opportunities

Responsibilities

The role will include managing OEM Packaging opportunities for distributed products and / or development of sterile and non-sterile case and tray packaging for spinal implants and instruments

This includes the Design History File documentation to support the development activities

Responsibilities may include the following and other duties may be assigned

Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products

Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering

Designs package exteriors considering such factors as product identification, Operating Room Workflow, aesthetic quality, printing and production techniques

Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants

Qualification

Medical device designSterile PackagingProject ManagementSix SigmaCREO softwareMinitabQuality Management SystemsRisk managementAttention to detailCritical thinkingCommunication skills

Required

Medical device design, development & manufacturing, experience of products with electrical functionality an advantage

Examples of critical thinking and proven project execution

Leading a cross functional teams and leveraging solid PM skills e.g. project planning, communication, risk management, etc. Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices, prioritizing safety, quality service, on-time execution

Lead team to define goals, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team

Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures

Use scientific problem solving methodologies e.g. DMAIC, process map

whys, Is/Is not, etc. Drive solid decision making

Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance)

Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges

Experience with medical devices sterilization methods (i.e., ethylene oxide, radiation, etc.) Experience implementing appropriate risk mitigation actions with knowledge of packaging or process and process Risk Management as per FDA & ISO standards

Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools

Working knowledge of SolidWorks or other packaging CAD programs (i.e., TOPS, SolidWorks, CREO, etc.)

Experience with Minitab or other statistical software

CREO drawing software

Sterile Packaging / Medical Device Packaging Development

Project Management skills, including MS Project timeline and design history file management