We are seeking an experienced, high caliber Manager, Packaging Engineering. Manages the planning and completion of packaging engineering projects, including the design and development of packaging, packaging processes, labeling processes, documentation, tooling, and fixtures in order to enhance productivity and product quality.
Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
*Impact this role will have on St. Jude Medical:*
* 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
* Participate in cross-functional teams
* 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 proceduresto ensure compliance to FDA, GMP and all other applicable agency regulations
* Ensure a safe work environment consistent with OSHA requirements and St. Jude MedicalPolicies
* 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.
* 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.
*Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:*
* 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
* Strong sterilization/microbiology knowledge
* High level of knowledge of manufacturing processes and quality standards
* Excellent written and verbal skills
* Proficient in reading and creating engineering drawings, including dimensions, tolerances and schematics
* Proficient and extensive working knowledge of packaging equipment for all related processes.
* Proficient and extensive working knowledge of packaging material and suppliers processes.
* Proficient and extensive working knowledge of lean manufacturing philosophies
* Subject matter expert of ISO 11607 part I & part II
* 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.
* Ability to work in a highly matrixed and geographically diverse business environment.
* 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 10-25%, including internationally.
*Your preferred qualifications and education:*
* Experience working in a broader enterprise/cross division business unit model preferred
#EL-LI
**Job:** **EN-Packaging*
**Title:** *Manager, Packaging Engineering*
**Location:** *Minnesota-Plymouth*
**Requisition ID:** *150001OC*
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