MDR- Packaging Engineer

Overview

Job Title
: MDR
- Packaging Engineer

Location
:
Lafayette, CO (Onsite)

Duration
: 12 Month+ Contract

Pay Range
: $50 to $50/hr

• 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.

• Medical device design, development & manufacturing, experience of products with electrical functionality an advantage
• Examples of critical thinking and proven project execution
• Leading cross-functional teams and leveraging solid PM skills (e.g., project planning, communication, risk management); 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)
• Why’s, 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 (e.g., ethylene oxide, radiation) and knowledge of risk mitigation actions with knowledge of packaging or process and process Risk Management per FDA & ISO standards
• Six Sigma/Design for Six Sigma experience, and/or knowledge of Process Excellence tools; working knowledge of Solid Works or other packaging CAD programs (e.g., TOPS, Solid Works, CREO)
• Experience with Minitab or other statistical software

• 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/ background
• Quality / Process Control / Assurance of Medical Devices

• 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.