Job Title: Manager, Global Packaging Engineering (Design/Process)-Medical Device
Responsible for the strategic direction and execution of all packaging process
engineering activities to support company's Global Operations.
This includes package testing, process development, error prevention technologies, and specification of materials and/or equipment to ensure proper configuration and production output requirements.
Accountable for the performance of packaging process engineering and packaging sustaining engineering teams in company Operations regionally.
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 Director, Global Packaging Technology.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Sets organizational priorities for packaging process engineering and packaging sustaining engineering teams within the company to ensure that established goals and objectives are being met in support of divisional NPD product launches and Global Operations initiatives.
Establishes best practices for the packaging functions globally in order to optimize speed-to-market, establish best in class approach, and ensure packaging quality and compliance.
Identifies improvements and directs the strategic planning process in the areas of regulatory compliance, new technologies, packaging flow enhancements, labor/material cost reductions, and auto-ID technologies to be utilized by Global Operations.
Ensures consistent approach to packaging processes and procedures, equipment specifications, verifications and validations.
Requires comprehensive understanding of concepts and principles related to packaging engineering and manufacturing. Maintains a working knowledge of competitive packaging systems, packaging methods and industry trends.
Ability to apply in-depth understanding of how packaging integrates with other functions within company's Global Operations.
Works directly with Quality Assurance, Manufacturing, Materials Management, Maintenance, and others in establishing and maintaining overall product packaging process requirements and related regulatory compliance.
Identifies and resolves complex technical, operational and organizational problems related to packaging.
Directs all activities within the group including the selection, development, and evaluation of engineers and technical support personnel.
Maintains all performance management schedule targets as defined.
Assists senior management in defining budgetary requirements for packaging initiatives, monitors spending against the plan, and engages in strategic planning process as required.
Authorizes capital expenses for the acquisition of production tooling, etc., to support key packaging projects.
Maintains current knowledge of standards for packaging of sterile and non-sterile medical devices, such as ISO 11607, Part 1 and 2, FDA 21 CFR part 820, etc.
Maintains active involvement in industry standards bodies in order to guide industry-wide packaging regulations and to ensure compliance with current practices and guidelines.
Implements LEAN manufacturing programs and Six Sigma methodologies.
Tracks, trends and reports results of improvement programs
Directly supervises managers and packaging project engineers in local and remote locations regionally.
FOR INTERNAL AND EXTERNAL RELATIONSHIPS:
Extensive contact required with other company 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 company's 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, 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 executive management team.
Packaging Process Engineering
Sustaining Packaging Engineering
Packaging Quality Assurance/Compliance
Minimum travel (<20%) may be required to support function at global sites. Education
Bachelor’s degree in engineering; Master’s degree preferred.
CPP preferred but, not required Experience
Eight 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. Competencies
Must have demonstrated ability to lead and direct others to the successful completion of projects. Must possess strong organization, communication, and interpersonal skills. Must be self-directed, with the ability to respond to the challenge of resolving day-to-day problems, as well as comprehensive issues by providing long-term solutions through strategic planning.
No sponsorship visa (H1-B, etc) candidates at this time, sorry.
Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:
COYOTE TECHNICAL & EXECUTIVE SOURCING
Director of Sourcing
3735 SW 8th Street, Suite 205
Miami, FL 33134
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