Manager, Packaging Engineering (31024733)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.
Manages the planning and completion of packaging engineering projects, including the design and development of packaging, testing procedures and strategy, packaging processes, documentation, tooling, and fixtures in order to enhance productivity and product quality. Develop innovative designs and create a strategy for how to incorporate those innovations into the next generation of products. Understand standards and how they apply to Abbott products.
Impact role will have on Abbott
- Provide technical leadership to packaging engineering staff regarding project prioritization, process validations, and continuous improvements
- Implement and manage resource planning and project management tools
- Support ongoing production and new product introductions
- Monitor and evaluate project and department progress and results
- Review and approve Quality Plans, Design Change Plans, Master Validations Plans, protocol, and written reports
- Drive continuous improvement of packaging engineering technical capabilities
- Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis
- Coach, manage and develop technical staff
- Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP and all other applicable agency regulations
- Ensure a safe work environment consistent with OSHA requirements and Abbott Policies
- Prepare departmental budgets and control expenditures to stay within spending limits
- Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback.
- Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.
- Maintains a safe and professional work environment.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
- BS in Packaging, Mechanical, or Manufacturing Engineering
- 10 years in a Medical Device Packaging Engineering function
- 5 years of people management experience
- Subject matter expert for medical device packaging
- Excellent written and verbal skills
- Proficient in reading and creating engineering drawings, including dimensions, tolerances and schematics
- Excellent working knowledge of writing protocols, preparing testing samples, testing samples, and making strong conclusions.
- Excellent firsthand working knowledge medical device package testing as well as proficient working knowledge of ASTM standards associated with medical device package testing.
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
- Ability to work effectively within a team in a fast-paced changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multi-tasks, prioritizes and meets deadlines in timely manner.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- Ability to travel approximately 15-25%, including internationally.
- Strong sterilization/microbiology knowledge
- High level of knowledge of manufacturing processes and quality standards
- Proficient and extensive working knowledge of lean manufacturing philosophies
- Experience working in a broader enterprise/cross division business unit model preferred.
- Proficient and extensive working knowledge of packaging equipment for all related processes.
- Proficient and extensive working knowledge of packaging material and suppliers processes.
- Subject matter expert of ISO 11607 part I & part II
- Ability to work in a highly matrixed and geographically diverse business environment.