Project Manager – PMO

Summary:

This role will be responsible for the cross-functional management (R&D, Manufacturing, Quality) of product development programs and projects by ensuring the successful definition, development and delivery of projects, and adhering to critical processes, standards, and best practices in order to provide on time delivery and significant value to our customers and patients.

Essential function/responsibilities

  • Key point of contact for all program related activities.
  • Leads, manages, coordinates, and reports on the cross functional activities for product development programs.
  • Develops detailed plans and schedules to ensure on-time completion of programs from concept through commercialization.
  • Develop project tasks, deliverables, dependencies and resource requirements.
  • Communicates frequently with business stakeholders regarding program status and identifies and resolves program problems, issues and risks.
  • Initiates action to identify and resolve program and project problems/issues and reports on mitigating steps and actions taken to ensure timely deliverables, program success and quality.
  • Provides regular status reports highlighting accomplishments, plans and issues.
  • Develops and promotes best practice process and/or methodology improvements and efficiencies across the organization.
  • Create, maintain and organize necessary documentation records.
  • Identify, document and communicate project risks and contingency plans.
  • Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders.

Required education/experience

  • Bachelor’s degree in Life Sciences, Engineering or related field.
  • 5-10+ years of program management experience in a regulated manufacturing environment.
  • 5-7 years working within new product development in the medical device space.
  • Understanding and ability adhere to established quality standards and regulatory compliance requirements for medical device or diagnostics.
  • Proven ability to lead programs from concept to market successfully.
  • Knowledge of Design Controls, GMP etc.
  • Demonstrated ability to work across multiple job levels to achieve results
  • Proven ability to manage multiple projects simultaneously in a deadline driven process.
  • Demonstrated ability to identify and implement process improvements to deliver programs and projects more efficiently.
  • Proven experience managing expectations and managing cross-functional teams.
  • Excellent interpersonal, written and oral communication skills with all levels of the organization.
  • Outstanding time management and organization skills.
  • Confident team leader and consensus builder with strong motivational skills.
  • Adept in problem solving and resolving conflict.
  • Able to manage internal customer relationships and expectations through negotiation and partnering.
  • Able to cultivate strong inter- and intra-departmental relationships that promote a positive, execution-focused work environment.
  • Ability to understand both technical and business vision and communicate it to both technical and non-technical partners.
  • Experience in an ISO environment and FDA regulated environment.

 

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