Cogmedix

Description:

The Engineering Project Manager is accountable for the support of the overall program success through the full customer engagement life-cycle, proposal offering through engineering design, and engineering builds, all in support of the design control process, while maintaining strict compliance with the Cogmedix Quality System, 21 CFR 820 and ISO 13485. The Engineering Project Manager will be responsible for supporting multiple Programs, and Programs may consist of single or multiple Projects within the Program, largely dependent upon size and complexity.  This role is responsible for maintaining the Project aspects of the program as defined but not limited to the responsibilities section below.

Responsibilities:

  • The Engineering Project Manager will be responsible for supporting multiple Programs within one customer or multiple customers through the guidance of the Engineering Program Manager.
  • Provide regular program status update reports to the Customer, Engineering Program Manager, Engineers and Senior Management that highlight status against key milestones, issues, risks and mitigations impacting performance, schedule and cost.
  • Ensure engineering dashboard reports are updated and distributed as required by the customer and program requirements.
  • Responsible for entering and maintaining Sales and Project information in PLM and ERP systems.
  • The Engineering Project Manager will at times need to interact directly with the customer in support of the Engineering Program Manager.
  • Responsible for strategic material sourcing, planning, management, excess and obsolete material disposition, and financial material monitoring with support for the Engineering Program Manager.
  • The Engineering Project Manager may be responsible for overseeing and reporting on program management activities, including, but not limited to ECO’s, redlines, DHR routings, product shipment and export control.
  • Support all Design and Production Engineering builds to ensure we meet or exceed our customers’ expectations and provide the support needed in a fast moving environment while staying complaint.
  • Responsible for supporting and maintaining customer business needs and expectations.
  • Responsible for structuring and maintenance of the Design History File (DHF) which contains all documentation which provides a design history of the project activities.
  • May have other duties and responsibilities as required.

Essential Requirements:

  • Commitment to compliance adherence.
  • Positive attitude, self-motivator, tenacious follow up, and excellent organization skills.
  • Superior customer service attitude and communication skills.
  • 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 required.
  • 3+ years’ experience with an FDA regulated medical device engineering preferred.
  • Strong interpersonal skills; must be capable of effectively establishing professional rapport with internal personnel and customers.
  • Must be strong in Microsoft products including Word, Excel, PowerPoint Visio and Project.
  • Experience with ERP and PLM systems is a plus, with Epicor and Omnify experience beneficial.
  • Must be able to climb stairs and lift up to 30 lbs.