MDR Packaging Engineer

North Haven, CT - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: MDR Packaging Engineer

Location: North Haven CT (Onsite)

Duration: Fulltime

Job Description:

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

Must Have:

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.

Nice to Have:

Change control of Medical Devices
Equipment Commissioning / Qualification
Process Validation
Computer System Validation (CSV)
Manufacturing Packaging and Laboratory Equipment
Technical experience (Trouble shooting) or any similar experience or background
Quality / Process Control / Assurance of Medical Devices

Top 3 technical skills that are required for the role:

CREO drawing software
Sterile Packaging / Medical Device Packaging Development
Project Management skills including MS Project timeline and design history file management
Years Experience Required: 2yr required; however 4 to 7 years of experience preferred.

Job Title: MDR Packaging Engineer Location: North Haven CT (Onsite) Duration: Fulltime Job Description: 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. Th...