Provide sustaining engineering support for manufacturing processes as well as support process improvement initiatives. Coordinate with cross functional teams to reduce scrap, implement improved methods, and processes to enhance the organization’s manufacturing capabilities, operational efficiency and effectiveness.
· Lead and/or assist PFMEA activities.
· Define, study, and understand process parameters and their impact on the manufacturing process.
· Provide leadership in troubleshooting process failures and implement controls.
· Provide leadership in SPC and Six Sigma implementation and provide training where needed.
· Lead and/or coordinate activities to determine correlation between scrap and process parameters.
· Develop, monitor, and/or control activities around statistical process control.
· Review and approve ECR’s in areas of responsibility.
· Lead projects and develop AFR’s for processes that require improvement.
· Lead and/or assist CAPA activities.
· Review processes for improvement opportunities.
· Initiate and maintain Item Masters, BOM’s and Routings per procedure and in accordance with engineering, quality, planning, and finance standards.
· Utilize problem-solving / root cause analysis techniques through team activity to identify key areas within each process opportunity.
· Coordinate process validation protocols and/or Design of Experiments to challenge each manufacturing process.
· Develop and nurture a continuous improvement culture, skill sets, and tools to enhance quality and operational excellence.
· Analyzes and plans workforce utilization, space requirements, workflow, and designs layout of equipment and workspace for maximum efficiency.
· Applies statistical methods to estimate future manufacturing requirements and potential.
· Develop action plans to achieve short and long-range goals, selection of new production methods and methods to monitor efficiencies.
· Develop Standard Operating Procedures (SOPs), work instructions / operating and maintenance procedures supporting manufacturing processes.
· Maintain knowledge of latest manufacturing methods used in the medical device industry to advance technologies.
· Develop tools to monitor process and to maintain control and taking corrective action when necessary.
· Assist in the improvement of pre-determined scrap limits.
· Perform Gage Repeatability & Reproducibility and Process Capability Studies
· Perform duties in compliance with SOPs and to company quality requirements.
· May supervise other engineering personnel.
· Other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
· Bachelors Degree in Engineering or related scientific field (Course in Statistics required).
· 7+ years manufacturing process improvement experience.
· Ability to work independently and effectively with cross-functional teams.
· Thorough understanding of manufacturing processes and ability to implement ideas.
· Detail oriented with strong analytical skills
· Detailed knowledge of project management planning and execution methods.
· Detailed knowledge of Medical Device process of validation including IQ, OQ and PQ preferred.
· Understanding of engineering change management methods and practices.
· Excellent organizational, troubleshooting, and problem solving skills required.
· Excellent written and verbal communications skills.
· Six Sigma and Statistics training and experience required.
· Strong communication skills and ability to communicate effectively with technical and non-technical staff.
· Lean Manufacturing experience highly desired.
· Statistical analysis software required. Minitab preferred.
· CAD experience required. Solidworks preferred.
· Solidworks CAD experience preferred.
· While performing the duties of this job, the employee is frequently required to walk; sit; use hands or arms (to finger, handle or feel objects, tools, or controls). The employee is occasionally required to stand; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear.
· The employee must occasionally lift 35 pounds.
· While performing the duties of this job, the employee frequently works near moving mechanical parts and is frequently exposed to fumes or airborne particles.
· The employee occasionally works in high places; in outside weather conditions and with toxic or caustic chemicals.
· The noise level in the work environment is normally moderate.
· The Personal Protective Equipment required to perform this job safely includes safety glasses and appropriate shoes. The employee would occasionally use ear plugs.