Packaging Engineer II - Exempt

LanceSoft Inc

Memphis, TN

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Change Control, Commissioning, Computer Systems, Cross-Functional, Design Failure Mode and Effects Analysis (DFMEA), Design for Six Sigma (DFSS), Document Management, Drawing Software, Electricity, Ethylene, FDA (Food and Drug Administration), File Management, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Implants, Laboratory Equipment, Leadership, Manufacturing, Medical Equipment, Microsoft Project, Minitab, OEM (Original Equipment Manufacturer), PTC Creo, Process Control Engineering, Process Management, Process Validation, Product Costing, Product Support, Project Design, Project Execution, Project Planning, Prototyping, Quality Control, Regulatory Requirements, Risk Management, Six Sigma, SolidWorks, Statistics Software, Sterilization, Support Documentation, System Validation, Team Lead/Manager, Test Plan/Schedule, Testing

LOCATION

Memphis, TN

POSTED

30+ days ago

Job Overview This role involves managing OEM Packaging opportunities for distributed products and the development of sterile and non-sterile case and tray packaging for spinal implants and instruments. The position requires the creation of Design History File documentation to support development activities. Key Responsibilities Design, develop, and test a wide variety of containers for the protection, display, and handling of products. Determine packaging specifications based on product nature, cost limitations, legal requirements, and protection needs, considering external variables such as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Design package exteriors, considering factors like product identification, Operating Room Workflow, aesthetic quality, and production techniques. Manage documentation and coordinate Good Manufacturing Practices (GMPs), supporting prototype line development in manufacturing facilities. Must Have Qualifications Experience in medical device design, development, and manufacturing, particularly with products having electrical functionality. Demonstrated critical thinking and proven project execution skills. Experience leading cross-functional teams with strong project management skills, including project planning, communication, and risk management. Familiarity with medical devices sterilization methods (e.g., ethylene oxide, radiation). Experience implementing risk mitigation actions with knowledge of packaging or 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 (e.g., TOPS, CREO). Experience with Minitab or other statistical software. Nice to Have Qualifications Experience in change control of medical devices. Equipment commissioning/qualification and process validation experience. Computer System Validation (CSV) knowledge. Experience with manufacturing, packaging, and laboratory equipment. Technical troubleshooting experience. Quality/Process Control/Assurance of medical devices. Design Failure Mode and Effect Analysis (DFMEA) experience. Technical Skills Required Proficiency in CREO drawing software. Experience in sterile packaging and medical device packaging development. Project management skills, including MS Project timeline and design history file management. Experience and Work Schedule Years of Experience Required: Minimum of 2 years required; 4 to 7 years preferred. Work Schedule: 40 hours per week, onsite 4 days a week. Product Line Support This position supports Spinal and Biologics products. Interview Timeline Interviews are scheduled to take place between June 30 – July 16.

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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