Design, develop, implement and improve assembly, packaging, and labeling processes to produce cost effective quality medical device products and systems. Provide manufacturing engineering expertise to create, document and implement required procedures and documents.
Essential Duties and Responsibilities:
• Work with project teams to identify issues and risks. During new product development, represent the Packaging Department/and or Production Department to ensure cost effective new product development and introduction into manufacturing assuring Design for Manufacturing (DFM).
• Develop a continuous improvement culture, skills sets and tools to enhance quality and operational excellence.
• Lead/support process improvement initiatives.
Introduce new equipment, products, and processes. Present process and equipment recommendations to Leadership Team with equipment reviews and plans for implementation. Manage equipment related capital projects with outside suppliers to meet project scope, cost, and schedule.
• Initiate new projects and be the Project Leader for key improvement initiatives, identifying best practices.
• Develop an understanding of the current manufacturing and packaging processes and identify targets for improvement in operation efficiencies.
• Develop manufacturing Work Instructions.
• Provide process and equipment expertise and support for daily clean-room sterile packaging efforts/and or production efforts.
• Develop action plans to achieve short and long-range efficiency goals, selection of new production methods, designs of production fixtures, and methods to monitor efficiencies.
• Lead and/or assist with implementation of packaging design/and or production specifications into manufacturing.
• Monitor timelines and project deliverables to ensure adherence with approved project plans for manufacturing process development.
• Develop protocols and coordinate validation of equipment and processes.
• Stay current with methods used in the medical device industry to advance technologies.
• Participate in defining Preventive Maintenance programs for clean room equipment/ and or production equipment associated with packaging or production activities.
• Drives automation to replace the manual process as much as possible
• Ensure Information and documentation is consistently accurate
• Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.
• Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
• Estimates production times, staffing requirements, and related costs to provide information for management decisions.
• Applies statistical methods to estimate future manufacturing requirements and potential.
• May supervisor other Engineering, Technician, Validation support personnel.
Education and Experience:
Bachelor’s degree required; preferrably in Engineering (Packaging, Manufacturing, or Mechanical)
7+ years of manufacturing process improvement experience.
Proven experience in leading process improvement projects.
Medical device manufacturing or FDA regulated environment preferred.
Experience in work flow optimization, work measurement, efficiencies.
Recognized process improvement training (Lean, Six Sigma) preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Ability to work independently and effectively with cross functional teams.Strong interpersonal and verbal/written communication skills
Thorough understanding of manufacturing processes.
Detail oriented with strong analytical skills.
SPC (Statistical Process Control) knowledge.
Strong communication skills and ability to communicate effectively with technical and non-technical staff.
Experienced user of MS Office Suite, SPC Software, and CAD.
Experience with planning and conducting tests to validate equipment and processes.
Experience in completing technical documentation for engineering and manufacturing.
Familiarity with clean room practices preferred.
Strong project management skills with proven ability to take a project from start to completion independently
Machine, Tools, and/or Equipment Skills:
Laser Marking, Bonding, cleaning equipment, finishing equipment, printing equipment, sealing equipment and custom fixturing.