|Description Main Objective:
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
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.
Provide process and equipment expertise and support.
Identify issues and risks to ensure cost effective new product development and introduction into manufacturing.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Requirements Education and Experience:
Bachelors degree in Engineering, Science or Mathematics.
3+ years of manufacturing process improvement experience.
Proven experience in leading process improvement projects.
Medical device manufacturing environment preferred along with experience working within manual assembly environments, preferably in suture assembly or 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.
New process development, including fixture development.
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.
Machine, Tools, and/or Equipment Skills:
Finishing equipment, sealing equipment, textile equipment and custom fixturing.
State or Province