Associate Manufacturing Engineer

Responsibilities and Authority

• Under the direction of the Manufacturing Engineering Manager and Manufacturing Engineers, the Associate Manufacturing Engineer will:
  • Compliantly implement and maintain Cogmedix procedures.
  • Collaborate with Program Managers, Manufacturing Engineers and other departments to analyze customer ECO’s and ensure effective implementation to the production floor through proper use of the Cogmedix ECO process.
  • As part of the ECO Process, manage the customer BOM, create part numbers and structure Supplier Relationships and costs.
  • As part of the ECO Process, generate and update DMR Indexes to ensure accuracy.
  • Ensure 100% ECO implementation accuracy.
  • Meet or exceed established ECO implementation performance metrics.
  • Effectively interact with customers and internal departments to create “value-add” propositions.
  • Working with all internal groups, identify trends, process gaps, suggest and assist in the implementation of corrective actions and process improvements.
  • Collaborate with internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs.
  • Promptly respond to manufacturing floor quality issues, taking appropriate action within the Cogmedix Quality System and continually building strong rapport with customers and suppliers.
  • Collaborate with Program Management, Quality, and Operations to develop optimal work order routings and Device History Records.
  • Working with Manufacturing Engineers and Quality Engineers, develop Redline Documentation.
  • Working with Manufacturing Engineers and Quality Engineers, generate Nonconformance documentation.
  • Working with the Manufacturing Engineers and Quality Engineers, assist in troubleshooting and the development of Rework Instructions.
  • Assist Manufacturing Engineers with the development and deployment of Lean Manufacturing Cells.
  • Working with the Quality Department, support the development of quality and inspection plans.
  • Assist Manufacturing Engineering Manager by performing regular audits of calibrated tools, tools requiring Preventive Maintenance and perishable floor stock items.
  • Assist the Manufacturing Engineers in the training of Assembly Technicians, Test Technicians and Quality Inspectors as needed.
  • Support new product introductions/transitions.
  • Working with the Manufacturing Engineers, generate process validation/qualification documentation and assist with the implementation of protocols and completion of reports.
  • Working with Manufacturing Engineers, prepare Process Flows, lead PFMEA’s and Value Stream Mapping.
  • Working with Manufacturing Engineers and Quality Engineers, assist in the creation of Risk Assessment documentation and development of Control Plans.
  • Perform other activities as directed.

Essential Requirements

• Positive attitude, self-motivator, and tenacious follow up required.
• Superior customer service attitude.
• Excellent teamwork, communication, and interpersonal skills.
• Exceptional attention to detail.
• Strong electro-mechanical orientation.
• Experience in ISO-13485 certified and cGMP organizations preferred.
• Proven problem solver with multitasking skills and the ability to prioritize tasks to align with the goals of the department and organization as a whole.
• Knowledge of IPC 610 and 620 standards beneficial.
• Ability to read and interpret engineering documentation including assembly drawings, detailed component drawings, electrical schematics, pneumatic schematics, and wire run lists.
• Must be able to climb stairs and lift up to 30 lbs.
• Associates degree in science, engineering, or manufacturing discipline preferred. Four or more years of related manufacturing experience and technical document control may be considered in lieu of certain educational requirements.
• 4+ year’s professional experience in medical subassembly and finished device manufacturing preferred.
• Advanced Level Skills in MS Word, Excel, Visio and PowerPoint such as keyboard short cuts, creating forms, table techniques, working with images, text, and pivot tables preferred.
• SolidWorks and EPDM experience preferred.