Packaging Engineer II

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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.

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, sales appeal, 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 SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results May act as a mentor to colleagues or may direct the work of other lower level professionals The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University) DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor Works independently with general supervision on larger, moderately complex projects / assignments Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments Contributes to the completion of project milestones May have some involvement in cross functional assignments Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area Communication and Influence: Communicates primarily and frequently with internal contacts External interactions are less complex or problem solving in nature Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Requirement:

Top 3 technical skills that are required for the role:
1 CREO drawing software
2 Sterile Packaging / Medical Device Packaging Development
3 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

Must Have

1 Medical device design, development & manufacturing, experience of products with electrical functionality an advantage 2 Examples of critical thinking and proven project execution 3 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, 5 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
4 Experience with medical devices sterilization methods (i.e., ethylene oxide, radiation, etc.) 5 Experience implementing appropriate risk mitigation actions with knowledge of packaging or process and process Risk Management as per FDA & ISO standards 6 Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools 7 Working knowledge of SolidWorks or other packaging CAD programs (i.e., TOPS, SolidWorks, CREO, etc.) 8 Experience with Minitab or other statistical software.
detail-oriented Packaging Development
develop new sterile packaging specifications
Sterile Packaging Design

Nice To Have
1 Change control of Medical Devices 2 Equipment Commissioning / Qualification 3 Process Validation 4 Computer System Validation (CSV) 5 Manufacturing, Packaging and Laboratory Equipment 6 Technical experience (Trouble shooting) or any similar experience or background 7 Quality / Process Control / Assurance of Medical Devices
Design Failure Mode and Effect Analysis (DFMEA)

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
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Location:
Memphis

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