Cogmedix

The Senior Manufacturing Engineering Manager will compliantly lead manufacturing engineering resources, processes, and continuously improve our manufacturing engineering processes, provide technical leadership in our SPL and process qualification processes, and technically manage specific customer programs.

 

Responsibilities

  • Provide engineering, operational, Lean manufacturing, Six Sigma leadership and mentoring. 
  • Collaborating with all department leaders, provide technical leadership to the organization with a focus on manufacturing engineering. 
  • Maintain positive, high performance environment that fosters extraordinary customer satisfaction.
  • Maintain compliance to the Cogmedix Quality System. 
  • Provide leadership to organization and manufacturing engineer(s) on their primary responsibilities, outlined below:
    • Engineering Change Orders
    • BOM management; creation of PN’s, supplier relationships
    • 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
    • Co-build and pilot build activities
  • Ensure Customer to Cogmedix BOM accuracy through various electronic means.
  • Provide technical support and leadership to SPL’s.
  • Collaborate with Project Managers and Quality Engineers to analyze Redlines, customer ECO’s and ensure effective implementation to the production floor through proper use of the Cogmedix ECO process, including reviewing and communicating with internal groups and customers on impacts of any changes (e.g., financial, inventory, WIP, open supplier orders, etc.). 
  • 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 PM’s and Quality Engineers to develop optimal work order routings and Device History Records.
  • Support the development of quality and inspection plans. 
  • Collaborate with internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs. Maintain compliance to the Cogmedix Quality System.
  • Effectively interact with customers and internal departments to create value propositions.
  • Working with all internal groups, identify trends and process gaps and suggest corrective actions and process improvements. 
  • Collaborate and support DFcx Engineering programs.
  • Train Manufacturing Engineers and Engineering Document Control Specialists.
  • Other responsibilities as directed.

 

Essential Requirements

  • Positive attitude, excellent communications skills, self-motivator, tenacious follow up, and superior organization skills.
  • Superior customer service attitude.
  • Bachelor’s degree in science, engineering, or manufacturing discipline.  Fifteen or more years of related manufacturing experience and technical document control may be considered in lieu of certain educational requirements.
  • 15+ year’s professional experience in medical subassembly and finished device manufacturing preferred.
  • Excellent organizational skills with a commitment to meeting deadlines and expectations while ensuring overall compliance and quality of delivery. 
  • Demonstrated ability to build effective business relationships across all levels of internal and external business.
  • Excellent technical, problem solving and analytical abilities.
  • Strong quality mindset a must. Experience with electronic quality management systems desirable.
  • Must be flexible, possess strong leadership and interpersonal communication skills; ability to manage multiple priorities and lead a team. 
  • Strong decision making capabilities and capacity to handle confidential information.
  • Advanced Level Skills in MS Word, Excel and PowerPoint such as keyboard short cuts, creating forms, table techniques, working with images, text, and pivot tables preferred.
  • A demonstrated commitment to company values.  
  • Strong electro-mechanical and opto-mechanical orientation.
  • Advanced working knowledge of Lean concepts and Six Sigma Black Belt training.