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Feb 26, 2019
Design, develop, implement and improve manufacturing 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 integrate with Engineers, Design Engineers, Quality Engineers and the Packaging Department/and or Production Department to ensure cost effective new product development and introduction into manufacturing.
Develop a continuous improvement culture, skills sets and tools to enhance quality and operational excellence.
Lead/support process improvement initiative.
Introduce new equipment, products, and processes. Present process and equipment recommendations to Leadership Team with equipment reviews and plans for implementation.
Initiate new projects and be the Project Leader for key improvement initiatives, identifying best practices.
Develop an understanding of the current manufacturing processes and identify targets for improvement in operation efficiencies.
Develop manufacturing Work Instructions.
Provide process support on manufacturing technical issues.
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.
Investigates and test in time reliability and quality improvements
Drive automation to replace the manual process as much as possible
Ensure Information and documentation is consistently accurate
Analyze and plan workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.
Confer with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
Estimate production times, staffing requirements, and related costs to provide information for management decisions.
Apply statistical methods to estimate future manufacturing requirements and potential.
Provide process and equipment expertise and support.
Identify issues and risks to ensure cost effective new product development and introduction into manufacturing.
Education and Experience:
Bachelor’s Degree in Engineering, Science or Mathematics required.
3+ years of manufacturing process improvement experience.
Proven experience in leading projects required.
Medical device manufacturing experience preferred.
Experience working in manual assembly environments, preferably in suture assembly on other medical device assembly.
Experience in work flow optimization, work measurement, efficiencies.
Recognized process improvement training (Lean, Six Sigma) preferred.
Industrial Engineering experience is a plus, but not essential.
Understanding of BOMs and routings.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Ability to work independently and effectively with cross functional teams.
Thorough understanding of manufacturing processes.
Detail oriented with strong analytical skills.
Strong communication skills and ability to communicate effectively with technical and non-technical staff.
Experienced user of MS Office Suite and CAD.
Experience with planning and conducting tests to validate equipment and processes.
Experience in completing technical documentation for engineering and manufacturing.
SPC (Statistical Process Control) knowledge.
Familiarity with clean room practices preferred.
Project management knowledge preferred.
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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220 Miracle Mile Suite B219, Coral Gables, Florida 33134
Phone: 305.809.7518 Fax: 305.520.0138