Cogmedix

Responsibilities

  • Compliantly implement and maintain Cogmedix processes and strategies relating to compliance, manufacturing, document control, and change control.
  • Collaborate with internal departments and Program Managers (PM’s) to analyze customer ECO’s and ensure effective implementation to the production floor through proper use of the Cogmedix ECO process, including reviewing and communicating impacts of any changes (e.g., financial, inventory, WIP, open supplier orders, etc.).
  • Effectively interact with customers and internal departments to create value propositions.
  • Perform the primary responsibilities outlined below with little supervision, adhering to Cogmedix processes and performance metrics where applicable:
    • Engineering Change Orders
    • BOM management; creation of PN’s, supplier relationships, standard costs
    • Process qualification/validation development and execution
    • PFMEA’s
    • Value Stream Mapping / Process Flows
    • Time Studies
    • Lean cell design and implementation
    • Procedure updates and training
    • Test fixture updates and validation
    • Production troubleshooting
    • Preparation of Redline documentation
    • Rework Instruction generation and review
    • Risk analysis
  • Support the new product introduction processes.
  • Working with all internal groups, identify trends, process gaps, and suggest corrective actions and process improvements.
  • Collaborating with Quality Engineers, ensure root cause, corrective, and preventive action are proactively pursued for components, assemblies, and finished devices that fail to meet acceptance criteria on first pass.
  • 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 vendors.
  • Collaborate with PM’s to develop optimal work order routings and Device History Records.
  • Support the development of quality and inspection plans.
  • As part of the Cogmedix team, assure all outgoing product is manufactured in a compliant manner.
  • 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.
  • Bachelor’s degree in science, engineering, or manufacturing discipline preferred. Five or more years of related manufacturing experience and technical document control may be considered in lieu of certain educational requirements.
  • Strong electro-mechanical orientation.
  • Experience in ISO-13485 certified and cGMP organizations preferred.
  • 5+ year’s professional experience in medical subassembly and finished device manufacturing preferred.
  • Proven problem solver.
  • Knowledge of IPC 610 and 620 standards beneficial. Certifications preferred.
  • Advanced Level Skills in MS Word and Excel such as keyboard short cuts, creating macros and forms, table techniques, working with images, text, and pivot tables preferred.
  • Advanced Level Skills in MS Visio such as creating Visio diagrams, creating custom styles and templates, cross functional flow charts, linking drawings to other MS applications, working with data, custom reports, and exporting is valuable.
  • SolidWorks and EPDM experience beneficial.
  • Must be able to climb stairs and lift up to 30 lbs.