Senior Program/Project Manager

About the Opportunity
We are currently seeking a Senior Program/Project Manager with a minimum of 7 years’ experience working in a medical device, FDA regulated, environment. This multi-faceted role will be responsible for managing new product development programs, projects and processes through lifecycle planning and coordinating cross-functional teams, focusing on delivering new products or upgrading existing products to meet BrainScope company goals.

  • Reports to Quality Assurance Manager
  • Full Time position
  • Competitive salary, stock option package and strong benefits

Job Summary
The Senior Program/Project Manager candidate will perform management activities related to programs and projects from initiation, planning, directing schedules, and budget/spend planning and tracking. The Senior Program/Project Manager candidate will be responsible for leading and coordinating cross-functional development teams for introducing new products and solutions in accordance with an FDA regulated product realization process and New Product Development (NPD) stage-gates in addition to sustaining product management.

The successful candidate must be able to drive impact across the organization, and leverage influence to knock down barriers and meet goals. The Senior Program/Project Manager will coordinate cross-functional teams within NPD scope and deliverables, as well as plan and manage organization readiness for successful launches (New Product Introduction) and product maintenance. The individual will also collaborate with key technology leadership team members to coordinate Product Realization stage-gate processes and reviews and deliver scheduled product releases.

  • Reports to Senior Director of Engineering and Manufacturing
  • Is a full-time position based in our corporate office, located in Bethesda, MD.
  • We offer a competitive salary, strong benefits and stock options to complete the package

Key Responsibilities

  • Lead and coordinate with the Project Managers assigned to the NPD Program
  • Lead cross-functional teams in developing NPD and NPI plans in accordance with Product Realization process
  • Plan and coordinate stage-gate deliverables
  • Plan, create and manage work breakdown structures for all key programs/projects
  • Develop timelines to achieve design transfer and first of kind  production ship date
  • Develop business and product risk mitigation plans
  • Prepare and execute communications plan for team and stakeholders
  • Develop organizational readiness plan for initial product launch
  • Manage the stage-gate deliverables schedule, including the first product shipment, to ensure that new products or solutions are launched successfully on-time
  • Work with department leaders to ensure proper allocation of resources and technical expertise for the programs or projects
  • Organize and facilitate regular team meetings and gate reviews, as appropriate
  • Communicate effectively across all levels of the organization, including key executives on program and project status
  • Prioritize and actively mitigate project risks in accordance with plan
  • Create and maintain project documentation including status reports, meeting minutes, NPD schedules, changes, issues, gate reviews, and team presentations. Ensures project documents are complete, current, and stored appropriately
  • Actively manage changes (scope, schedule and cost) including leading and producing impact analysis
  • Work with Executive leadership and to identify and implement NPD and sustaining process improvement plans
  • Manage product requirements, cost, pricing, terms and conditions and any-related contractual flow-down through the organization
  • Provide periodic program updates (Program Status Report) of status related to any internal or contractual milestones and problem/high risk areas (e.g., technical, cost, and schedule)
  • Minimal required travel (less than 5% of time)


  • Bachelor’s degree in Business or Engineering from an accredited institution.
    • Preferred: Bachelor’s or Master’s degree in Computer, Electrical or other Engineering-related discipline
    • Preferred: MBA from an accredited institution
  • Minimum of 7 years’ experience in Program/Project Management OR Program Management with Engineering and/or New Product Development and/or New Product Introduction (commercialization) experience
  • PMP, PgMP or equivalent certification or experience
  • Background in Agile or alternate model
  • Medical Device Product development experience
  • Key Success Criteria
    • Experienced in New Product Development (NPD) programs
    • Proven Leadership skills - capability to lead change across functional boundaries
    • Fully demonstrating proficiency in Program and Project Management methodologies, processes and tools
    • Strong analytical skills and business acumen
    • Project management and team building skills
    • Excellent written and verbal communication skills with strong presentation aptitude and public speaking experience
    • Proficient with MS Office suite of tools
    • Strong understanding of product development process through a phase gated process
    • Understanding of basic engineering principles with respect to software, devices or systems
    • Must be legally authorized to work in the United States without company sponsorship
    • Experience with Microsoft Office Suite

Qualified applicants are encouraged to send their resume and a cover letter including availability to 


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