MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)

• 5+ years as a Project Manager, or equivalent experience in the development of combination products and/or medical devices.
• BS in Engineering, Biology, Physics, or related Scientific discipline
• Technical management of programs in both direct or matrix reporting organizations, coordinating, and leading multiple team members through the execution of program deliverables.
• Experience with the total lifecycle management of medical device programs, with preferred experience in the clinical and commercial development of drug delivery systems (combination products).
• Understanding of DHF elements, and their integration through the medical device development process.
• Ability to work independently, meet deadlines, and work as a dedicated member of a team.
• Direct experience developing design history file documentation in quality management systems.
• Exceptionally strong writing skills, extremely well organized and strong attention to detail.
• Very strong people skills and the ability to build relationships with stakeholders, staff, Board members, and external partners.
• Proven ability to manage confidential information with absolute discretion.

SOME OF THE THINGS YOU’LL DO:

The Project Management Consultant reports directly to the Associate Director Project Management and will develop, lead, and participate in activities and duties and noted below. This is a fantastic opportunity to help us develop a Project Management Department – you will work together with the Associate Director and other internal stakeholders to create and define the best project management practices and systems for our business and help lead us into a exciting future full of opportunity!

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential functions include, but are not limited to the following:

• Assists in the Development (in collaboration with sales and technical directors) of complex estimates for statements of work with the SCI systems.
• Review resource management of current and future projects to ensure projects are appropriately sourced.
• With the Technical Director, transition projects from sales to the technical team. Provide backup to the sales operations team.
• Takes direction from the Association Director to ensure the professional services software is current and well maintained. Trains new staff in the use of the software, ensuring the system is maintained and adequate for business use.
• Reviews SCI projects regularly to ensure deliverables and budgets are being met. Escalates issues to the Technical leadership.
• Provide support to the organization for critical meetings, projects, and initiatives.
• Provides project management oversight for multiple programs in both direct or matrix reporting teams coordination team members through the execution of program deliverables.
• Coordinate project kickoff process through creation of supporting project documentation, scheduling, and systems organization.
• Coordinates and leads with the Technical Directors, project reviews in the form of Dashboard and Steering Committee meetings.
• Assists with the development SCI best practices for project management establishes expectations for project leadership with Technical Staff, and trains new hires.
• Assists with project management oversight for multiple medical device programs with clients and internally.
• Provides project management and leadership of SCI internal process improvement and system initiatives.
• Manages, analyzes, and maintains KPI’s.
• Organizes and schedules technical discussions for internal and client teams as a technical subject matter expert on the development of drug delivery systems.

Requirements: