|Job Description :
||Responsible for the management and execution of packaging process engineering activities to support Smith & Nephew Global Operations at the site level. This includes process development, error prevention, and specification of equipment to ensure proper configuration and production output requirements. Responsible for ensuring that packaging processes for all product lines are quality compliant, functional, cost effective, and meet targeted regulatory and quality requirements. Reports to the Director, Global Packaging Technology- Americas.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Manage all activities within the team including the selection, development, and evaluation of engineers and technical support personnel. Maintains all performance management schedule targets as defined.
Provides roadmap for team capability enhancements and training opportunities to support site ongoing and future needs.
Develops, leads, and implements packaging process qualifications and equipment installation projects for new product introduction.
Manages process team in writing and performing FAT’s, SAT’s, IQ’s, OQ’s, PQ’s and other packaging process specifications. Performs or oversees package testing activities as required. Maintains complete records of packaging process and equipment design activities, test data, and other pertinent information for each project.
Coordinates capital projects, process improvements, and cost reduction initiatives with multi-functional teams from Marketing, Manufacturing, Quality, Packaging Development, Facilities, Finance, and outside suppliers and equipment manufacturers.
Assists management in defining budget requirements for specific projects, equipment, packaging under construction/retirements monitors costs for assigned projects. Initiates purchase requisitions for prototypes, tooling, materials, and other project-related expenses. Facilitates the preparation packaging capital expenditure alignment requests and approval process to completion as needed.
Manages approved CAPEX project spends to commitments and provides ongoing periodic forecasts to planned and active project spend.
Assists and participate in the resolution of packaging-related problems on the shop floor through the site Management Operations System structure. Performs Gemba walks to the shop floor regularly to understand current issues. Investigates packaging and labeling processes related concerns and liaison between support groups as needed to maintain the right level of support team focus and urgency.
Coordinates and monitors technically challenging packaging projects and programs from inception through implementation. Establishes appropriate project schedules and prepares project reports periodically to outline progress.
Researches technical matters related to packaging, automation, workflow, testing, sterilization, etc., and prepares technical reports as required. Investigates and develops the use of new equipment, processes and materials related to packaging projects.
Provides strategic and tactical Packaging technological process plan/support for Operational Excellence improvements such as LEAN manufacturing programs/Six Sigma methodologies. Tracks, trends and reports results of improvement programs.
Manages packaging related product router update changes resulting from project changes or continuous improvement activities.
Is knowledgeable with current standards for packaging of sterile and non-sterile medical devices, such as ISO 11607, Part 1 and 2, FDA 21 CFR part 820, etc. Support serve as site based packaging process SME for internal and external site audits as needed.
Works to ensure packaging systems are consistent with current packaging standards for sterile and non-sterile medical devices. Maintains an awareness of current packaging and sterilization advances and technologies relative to medical devices and/or other related health care products.
Directly supervises packaging process engineers, technicians, interns and other support personnel within the department.
FOR INTERNAL AND EXTERNAL RELATIONSHIPS:
Extensive contact required with other S&N departments, divisions, and business units. Primarily interacts with Marketing, Product Development, Manufacturing, Materials Management, Distribution, Purchasing, Procurement, Quality, Regulatory Affairs, and executive management. Extensive contact required with suppliers, customers, company sales personnel, company subsidiaries, and consultants.
FOR ORGANIZATIONAL INFLUENCE:
Works with key areas in determining and setting direction for overall packaging program across Smith & Nephew Global Operations. Position has considerable influence on company policy, methods, and procedures regarding product packaging.
LIMITS OF AUTHORITY:
All decisions and recommendations are subject to review by senior management.
OTHER JOB FUNCTIONS these are non-essential job duties and responsibilities as assigned by the supervisor.
Maintain positive, productive relationships with Research & Development, Manufacturing, Quality, Procurement, Marketing and suppliers. Conduct work in professional manner.
Provide effective communication including face to face interactions, written/electronic updates and full technical reporting and recordkeeping. Ability to present conclusions and recommendations to senior management team.
Minimum travel (up to 10%)
Bachelor’s degree in engineering; Master’s degree preferred.
Five (5) years’ experience in an operations role related to the design, development, and/or manufacture of medical device or healthcare product packaging; or a related field. LEAN manufacturing and/or Six Sigma methodology preferred.
Project and time management, able to work independently and within cross functional team environments.
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.