The Project Manager is accountable for the overall program or project success, with oversight from a Program Managers, Senior Program Managers, the Scaled Product Launch™ Manager or the Vice President of Relationship Development and Program Management, throughout the full product lifecycle. This includes proposal generation to manufacturing through all stages of the SPLTM (Scaled Product Launch) and into 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.
Project Managers will compliantly implement and maintain Cogmedix Program Management and Customer Management strategies through direct management of delegated tasks (projects) or accounts from Program Managers, Senior Program Managers, the Scaled Product Launch™ Manager or the Vice President of Relationship Development and Program Management. At the discretion of the Vice President of Relationship Development and Program Management, Project Managers may be assigned to be the direct contact on a customer or multiple customer accounts and take on certain responsibilities of the Program Manager Job Description, QF-6.2.2-JD-30.
Project Managers may be responsible for overseeing and reporting on program management activities, including, but not limited to those related to BOMs, drawings, work instructions, ECO’s, redlines, DHR routings, process validation, product shipment and export control, job release, open order reports, and other support as required.
Project Managers may collaborate and support production scheduling, manufacturing lead times, coordination of company resources with Operations, and the control of project costs in order to achieve project success and quoted profitability.
Project Managers will frequently communicate directly with customers, ensuring at all times compliance with the Cogmedix Quality System.
Project Managers are responsible for identifying customer requirements and determining if additional documentation is needed to meet customer expectations and compliance requirements.
The Project Manager participates in the customer quotation process and may manage some or all of the following:
Reviews quote package and determines labor and material requirements.
Leads the quotation development to live order conversion process with guidance from their direct supervisor or the Scaled Product Launch™ Manager.
May communicate directly with the customer regarding questions that arise during the quotation process.
Maintains adherence to the formal Quotation Log and provides updates to Program Managers and management as needed and ensure all quote packages are filed electronically for future reference for a minimum period of five years.
Project Manager may perform Sales Order entry and be responsible for Purchase Order Confirmations in accordance with released procedures.
Project Managers may be responsible for DHR creation or providing direction to Associate Project Managers on DHR creation.
Project Managers may be responsible for job creation at the direction of Supply Chain Management and support the full RMA process from RMA creation through RMA shipment.
Project Managers are responsible for maintaining accurate information for the project and reporting on key metrics such as MRB, ECO implementation, customer OTD (on-time delivery), excess inventory and more.
Project Managers may support Engineering Service projects under Cogmedix’s DFcxTM (Design for Compliance & Excellence) program and perform tasks such as Project Entry, Weekly Project Reviews and Communicate Engineering Dashboards directly to the customer.
May have other duties and responsibilities as required.
Commitment to compliance adherence.
Positive attitude, self-motivator, tenacious follow up, and excellent organization skills.
Superior customer service attitude.
Associate or Bachelor degree preferred, preferably in a science, operations, or engineering discipline. Applicable professional experience may be considered in lieu of certain educational requirements.
3+ years Project Management required. Bachelor’s Degree in Engineering and/or professional experience in engineering, manufacturing, supply chain, quality engineering, or other experience 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 is preferred.
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, various levels of management, and customers.
Should be strong in Microsoft products including Word, Excel, PowerPoint. Experience with Visio and Project preferred.