Cogmedix

The Program Manager is the primary point of contact for Cogmedix customers and is responsible for leading Exceptional Customer Experiences. The Program Manager is accountable for the overall program success throughout the full product lifecycle, from proposal generation to manufacturing through all stages of the SPLTM (Scaled Product Launch) and full production, while maintaining strict compliance with the Cogmedix Quality System, 21 CFR 820, and ISO 13485. Success is measured by business metrics, audit results, and customer satisfaction survey.   

Responsibilities:

  1. Program Managers may be responsible for multiple Programs within one customer or multiple customers.   
  2. Principal point of contact with customer, responsible for building quality relationships with key stakeholders that result in a valued and trusted relationship, customer satisfaction, and continued strategic business expansion opportunities. This begins by early assignment of a Program Manager as the leader of the Customer Success Team. It is measured using customer satisfaction surveys that are sent to the customer and other feedback that may be provided by customers.
  3. Provide regular program status update reports to customers and senior management that highlight status against key milestones, issues, risks and mitigations impacting performance, schedule and cost.
  4. Principal point of contact with senior management, responsible for presenting regular concise program status updates, and ensuring timely resolution to critical program issues.
  5. Responsible for Program performance including:
    1. Working directly with the Scaled Product LaunchTM Manager to ensure that all product launches are successful and driven through the SPL Process.
    2. Working with Supply Chain and Planning to ensure job closings are completed in a timely manner and support resolving open purchase order activities as well as developing the proper material management strategy.
    3. Working directly with Manufacturing Operations to achieve operational metrics from OTD performance to cycle-time to quote goals.
  6. Ensure that all customer projects are achieving financial goals, including:
    1. Meeting monthly shipments against forecast to achieve monthly revenue and gross margin goals.
    2. Obtain customer Purchase Order coverage for excess material and timely disposition of material removed from customer Bill of Materials.
    3. Work directly with Supply Chain to monitor MRB and achieve timely disposition, driving MRB totals to $0 and minimizing aging of MRB. 
    4. Ensure Manufacturing Cost Accuracy by confirming system manufacturing costs are equal to or less than quotation. 
    5. Periodically reviews customer inventory status and inventory turns with Supply Chain to ensure proper supplier order alignment and practices are in place (e.g., KanBan, VMI, etc.) to minimize inventory and maximized turns.
  7. Responsible for the change management process with the customer to ensure appropriate and timely coverage for additional efforts, out of scope activities, material disposition, and communicating impacts internally and/or to the customer (e.g., financial, inventory, WIP, open supplier orders, etc.).
  8. Responsible for coordinating with peers, Quality, and Operations for identifying resource needs and allocation, and resolving any identified conflicts that may impact program success.  
  9. Responsible for customer contract adherence and Purchase Order management, this includes ensuring Sales Order alignment in Cogmedix’s ERP and managing overdue backlog.
  10. Responsible for defining and maintaining customer business needs and expectations.
  11. Own customer relationship management, including risk management and conflict resolution.
  12. Support growth of the business by supporting New Business Development opportunities and identifying new opportunities at existing customers, including Engineering Service projects under Cogmedix’s DFcxTM (Design for Compliance & Excellence) program.  
  13. Responsible for ensuring that assigned customer projects under Cogmedix’s DFcxTM are delivered on-time and within budget. This includes communicating engineering dashboards to the customer and ensuring project proposal revisions are delivered to customers for requested scope changes and/or schedule or cost deltas versus estimates.
  14. May be responsible for overseeing training, performance, and growth of Associate Project Managers and Project Managers.
  15. Program Managers collaborate with Executive Vice President and General Manager, Vice President of Sales and Program Management and the Senior Vice President of Corporate Quality and Compliance with regard to Manufacturing and Quality Agreement reviews as required.
  16. Responsible for initiating actions to prevent nonconformance and recommends or provide solutions through designated channels.
  17. Performs other duties as required.

Essential Requirements:

  • Commitment to compliance adherence.
  • Positive attitude, self-motivator, tenacious follow up, and excellent organization skills.
  • Excellent, professional, and respectful communication, cooperation, and collaboration skills. 
  • Superior customer service attitude and communication skills.
  • Associate’s or Bachelor’s degree preferred, preferably in a technical discipline. Applicable professional experience may be considered in lieu of certain educational requirements. 
  • 5+ years Project or Program Management preferred. Professional experience in engineering, manufacturing, supply chain, quality engineering or other roles in the medical device industry may be considered in lieu of direct project management experience.
  • Experience in an ISO 13485 and FDA cGMP compliant environment highly desirable. 
  • 3+ years’ experience with an FDA regulated medical device manufacturer preferred.
  • Strong interpersonal skills; must be capable of effectively establishing professional rapport with internal personnel and customers.  
  • Should be strong in Microsoft products including Word, Excel, PowerPoint. Experience with Visio and Project preferred.