Job Description Summary
This position is part of the Operations Organization for the BD Diagnostic Systems Segment and reports directly to the Package Engineering Manager. This position supports the primary organization strategic initiatives by driving growth through the development and implementation of innovative packaging solutions and by funding growth through initiating and driving cost savings and standardization efforts. This role is responsible for managing complex packaging projects from the concept to the commercialization phases for new and existing products in a cross-functional environment working closely with the following functional groups within the Sparks, MD location as well as ex-Baltimore sites: Manufacturing, Procurement, Marketing, Quality Management, Regulatory Affairs, R&D, and Distribution. This position also requires working with selected external technical teams at packaging material suppliers. This function combines strong technical expertise in packaging applications, project management and cross functional team skills to provide a complete source of packaging services (concept development, feasibility, performance testing, validation and commercialization).
Manages project activities to achieve project and business objectives, including budget, timing, and performance considerations.
Provides status reports to management on a timely basis, including Leadership and Core Teams. Capable of contributing effectively as an Operations Core Team Member on product development projects.
Responsible for packaging related projects and packaging types in assigned categories to include: package design, packaging process development and optimization, cost reductions and supporting manufacturing efficiency efforts as well as identifying packaging related defects and driving resolution.
Lead the conceptualization, initiation, development, and commercialization of new and improved packages and processes including design generation, prototype development, specification development, functionality testing, and mold qualifications as necessary. This would include the coordination and implementation of primary, secondary and tertiary packaging from concept to implementation.
Manage and lead packaging projects effectively and professionally to ensure agreed upon key business objectives and product launches are met. This would include leading multi-functional teams as appropriate.
Provide timely package engineering support for development and ongoing production needs of all packaging materials related to the manufacturing of related products.
Ensure package and product compatibility by identifying and executing package performance testing.
Specification development and component validation are core competency requirements.
Develop, justify and execute capital projects related to packaging (i.e. molds)
Assists in development of technical strategy to accomplish project goals.
Provides input to Package Engineering Manager to accomplish departmental and organizational strategies.
Assists in the development of process and packaging equipment specifications for automation equipment.
Search and develop new processes and equipment for new packaging.
Works with product design and development teams to ensure robust manufacturability of new packaging systems.
Applies statistical, six-sigma and lean manufacturing methodologies to ensure optimization of new products and production equipment as it relates to packaging systems.
Works closely with suppliers to eliminate process variables and maintain reliable flow of packaging materials.
Support new product development programs from initial design phase to commercialization with concentration on process design, validation and planning.
Evaluate product designs for manufacturability and provide feedback to R&D. Strong R&D new product development tie-in using Design for Manufacturing (DFM) principles.
Develop, validate and maintain manufacturing processes both in-house and at suppliers.
Suggest and implement programs for cost reduction, reduced cycle time and improved quality.
Interface with R&D, Marketing, Procurement, Quality Assurance, Finance and outside suppliers to solve manufacturing and design related problems.
Conduct root cause analysis of all manufacturing related problems, provide and implement problem resolution and corrective action.
Required Knowledge and Skills:
Solid communication skills, both written and verbal, which deliver information as well as clear positions on issues to be addressed and potential solutions.
Ability to work effectively across cultural differences with manufacturing teams world-wide, including but not limited to: Canada, Puerto Rico, Germany, China and Japan.
Strong teamwork, leadership and project management skills, to include: project planning, development and management as well as maintaining project budgets and spending.
Ability to determine priorities based on key business objectives and management of multiple projects simultaneously.
High degree of creativity and ability to work independently yet collaboratively with other functional areas.
Ability to interact well with peers, subordinates and senior and leadership team personnel in multi-disciplinary teams.
Required Education and Experience:
BS Degree in Package Engineering, Plastic Engineering, Plastic Technology or related discipline.
10+ years Package Engineering experience with preferred background in the healthcare or medical device manufacturing industry or at least a FDA-regulated industry.
6-10 years’ experience with some combination of packaging systems / materials preferred including: Extrusion and Injection Blow molding, Injection molding and/or glass molding, bottle / cap configurations, laminated structures, folding cartons, corrugated and labeling.
6-10 years’ experience with some combination of liquid filling equipment, heat sealing, molding, thermoforming and / or sterilization processes preferred.
The preferred candidate should have solid knowledge of current manufacturing processes related to plastic injection molding and blow molding.
Experience with rapid prototyping methods and recommendation of resources.
Working knowledge of most thermoplastic resins, molding presses and auxiliary support equipment.
Experience with process and mold validations, equipment qualifications, material selection, corrective action and vendor selection/qualification is required.
Knowledge and understanding of tooling prints, part prints, inspection procedures and SPC analysis.
Demonstrate troubleshooting and problem solving solutions through the use of Six Sigma disciplines/methodologies and DOE.
Comprehensive knowledge of GMP and ISO requirements.
Proficient with software programs including Solid Works, AutoCad, Microsoft Office, MS Project or equivalent and Visio.
Excellent written and verbal communication skills for dealing with all levels within the organization as well as with suppliers.
Demonstrated success handling multiple priorities and working in a fast paced, regulated environment.
Must be a team player with demonstrated ability to work independently.
Primary Work Location
USA MD - Baltimore
US BD 1st Shift 8am-5pm (United States of America)