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Sr Project Manager (Medical Device)

TekOne IT Services Pvt. Ltd.
Andover, MA Contractor
POSTED ON 12/15/2024
AVAILABLE BEFORE 4/14/2025
Role: Senior Project Manager (Medical Device)

Location: Andover MA 01810

Duration: 24 months

Summary

The Sr. Project Manager is responsible for leading cross-functional teams, in introducing of injection products that help people with diabetes live healthier lives. Scope includes R&D specific workstreams supporting major initiatives or major product development programs.

Job Responsibilities

  • This position offers a unique opportunity to lead and manage a portfolio of projects that are critical to the continued viability of the business.
  • Lead a cross-functional team comprised of R&D Change Managers and Engineers for coordinating projects which impact compliance, form/fit/function, cost savings, line extensions and other business opportunities across all plants, quality, and marketing.
  • The program manager works at the interface of multiple stakeholders and will serve as a liaison between business leadership, functional management, and individual project leaders.
  • Duties involve consolidating, prioritizing, resourcing, and monitoring progress of cross-functional projects.
  • Drive project prioritization utilizing appropriate model / methodology and get consensus across functions to focus on projects that create value for the Business.
  • Reports on the progress of the program with an agreed frequency on quality, status, time, and costs to senior management.
  • Work with managers from different functions to ensure allocation of resources and discretionary spending is sufficient to achieve target completion dates.
  • Work with individual project team members to ensure appropriate planning and rigor is maintained to ensure success of these projects.
  • Additionally, help to implement and lead the use of a global portfolio management tool for cross-functional management.

Experience & Education

  • Must have a bachelor’s degree in a technical field, preferably in an engineering or scientific discipline, with at least five (5) years experience in engineering project management of Class II or III medical device projects.
  • Experience with life cycle management of products designed for high volume manufacturing
  • Strong demonstrated organizational leadership skills, interpersonal, influence, and conflict management skills.
  • Solid technical and project management judgment, strong communication skills.
  • Demonstrated experience in project planning, management, and budgeting with an orientation towards building and leading effective teams.
  • Experience in managing multiple work streams and competing priorities.
  • Experience in creating and monitoring metrics and reporting dashboards.
  • Experience with, and thorough understanding of disciplined product development processes, regulatory, and quality requirements.
  • Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
  • Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes

Knowledge, Skills And Abilities

  • Technical Skills: Proficiency in tools, such as MS Project, Celoxis, Monday.com
  • Soft Skills: Strong problem-solving skills, excellent communication abilities, and the ability to work effectively in a team environment.
  • Certifications: Relevant certifications - PMP

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