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Project Management Director

 

Neural Analytics, Inc. is an LA-based medical device company that is addressing a global unmet need for immediate and non-invasive diagnosis of brain disorders, including stroke, dementia and trauma. The company was formed in 2013 and has been cultivating its cutting-edge technology for the past 4 years.  Neural Analytics is an agile and energetic workplace, staffed by a growing, high-performing team.

We are currently searching for a dynamic Project Management Director. This role reports to the Director of Project Management. The Project Management Director will work independently to plan, direct, coordinate and manage specifically identified products through our product lifecycle. This position is responsible for all goals and objectives of a project including completion within the prescribed time frame and funding parameters.

Key Responsibilities

  • Implement Product Development Process (PDP); lead teams to complete activities to current policies and practices; keep documentation organized; identify process improvements
  • Responsibility includes conceptualizing and defining new and/or modified product specifications while also providing accurate and timely recommendations of proposed processes, equipment, tooling and fixtures along with costs
  • Effectively manage all areas of projects including initiating, planning, executing, controlling and closing of projects
  • Provide regular reporting and visibility on project statuses; leads management reviews and project meetings; develops and manages agendas, minutes and follow up with action items
  • Develop and maintain program management deliverables as defined by Neural Analytics’ Quality Management System, ISO 13485 and 21 CFR 820
  • Execute multiple high quality integrated cross-functional project plans including development of project charters, schedules, milestones, budgets, risks, issues and resources to meet project goals; incorporate technical, resource, operational and regulatory requirements into project plans
  • Manage technical challenges of applications and new product development; identify, communicate and manage all levels of risk to senior management
  • Show proven expertise in functional areas and carry out leadership duties; contribute to progress of a team and effectively leverage a network of company resources
  • Escalate unexpected events impacting project schedule, budget & resources to management
  • Define and oversee the business and financial results expected from a project; develop implementation plans, conduct risk assessments and develop and implement strategy; must ensure that project will effectively integrate with existing competing project and strategies to both short and long-term business goals
  • Execute multiple high quality integrated cross-functional project plans including development of project charters, schedules, milestones, budgets, risks, issues and resources to meet project goals; incorporate technical, resource, operational and regulatory requirements into project plans
  • Manage the administration for project submissions and approvals through the agreed prioritization and approval process, maintaining a pipeline of approved projects
  • Participate in implementing improvements to project management processes, tools and infrastructure to ensure ongoing efficiency across organization
  • Responsible for cross-functional communications; act as liaison between teams and executive management; lead phase and business reviews as well as all other key communications

Qualifications:

Minimum

  • Minimum of Bachelor’s Degree in management, business, or related field (with PMP Certification).
  • Minimum 10 years of experience & 3-5 years at a managing level working with R&D, Supply Chain, Operations, Regulatory, Quality, and Marketing to deliver projects for commercial release.
  • Experience leading multiple 510(k) and PMA projects through development
  • Proficient in statistical analysis and probabilistic determination (Monte Carlo, etc)

Required Knowledge, Skills & Experience

  • Extensive experience providing practical direction on information and Management platforms.
  • Experience using with project management, SDLC methodologies.
  • Show understanding of work breakdown structures, critical path analysis and scenario based project scheduling to include budget and resource estimations
  • Demonstrate strong leadership qualities including conflict/issue resolution, ability to run a project/serve as project manager on a team and ensure successful project lifecycles
  • High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction
  • Extremely strong analytical and problem -solving skills.
  • Proven strong negotiating and consensus building abilities.
  • Proven skills to work effectively across internal functional areas in ambiguous situations.
  • Highly self‐motivated, self‐directed, and attentive to detail.
  • Ability to effectively prioritize and execute tasks in a high‐pressure environment
  • Team creation and management experience with the ability to manage and motive teams

Preferred Qualifications

  • PDP / PMI Certification
  • Medical device experience or development in a regulated environment
  • MBA Project Management

 

About the company: 

Neural Analytics, Inc. is an LA-based medical device company that is addressing a global unmet need for immediate and non-invasive diagnosis of brain disorders, including stroke, dementia and trauma. The company was formed in 2013 and has been cultivating its cutting-edge technology for the past 4 years. Neural Analytics is an agile and energetic workplace with a growing, high-performing team.

 

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