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Sr Medical Device Program Manager

2 months ago

Tewksbury, United States Talent Groups Full time

Sr Medical Device Program Manager

FULL-TIME

Must be willing to work onsite in the greater Tewksbury, MA area 4 days/week


Job Description

  • This position is responsible for managing programs consisting of product development and/or sustaining projects within the Program Management Office. “Project Owner”; Responsible for overall project planning, execution, and closure to achieve the program/project objectives (scope, schedule, cost, quality) with adherence to SOPs. Accountable to self, team, and organization to deliver results.
  • “Project Advocate”; Leads the cross functional team (CFT) throughout the product development lifecycle, from conceptualization, through definition, design, realization, validation, to production release of new or existing devices, systems, IT, and/or related accessory products.
  • “Face of the Project”; Responsible for communication of key project/program performance metrics, status, key decisions, risks, issues and mitigation strategies to CFT and management at all levels.
  • Responsible for the project DHF and other required documentation.
  • Proactively manages program and project risk (risk identification and mitigation).
  • Collaborates with department managers regarding resource planning, schedules, budgets, and quality of deliverables. Leads and coordinates activities with suppliers, contractors, and other internal entities to ensure that work is delivered as needed for assigned projects.
  • Contributes to program planning, strategic planning, budgeting, and process improvement initiatives.
  • Applies project management best practices while ensuring compliance to internal SOPs, QMS and FDA and other industry regulations.
  • Performs other duties as needed and assigned.


Your Qualifications

Education:

  • BS in technical discipline (ME/EE/SW/Biomedical/Systems); MS preferred.
  • Medical devices background / education preferred.

Related Experience:

  • 10+ years in the development of complex embedded systems, PC-based products, electro-mechanical systems, or medical devices.
  • 5+ years project management in a cross-functional environment including multi-locational or global teams.
  • Medical device experience is preferred.
  • Contractor and Supplier management.


Special Competencies or Certifications:

  • PMP Certification.
  • Thorough understanding of developing products using a structured new product development process.
  • Ability to work successfully across functional lines.
  • Knowledge of GMPs as defined by the FDA; familiarity with UL, CSA, IEC and other various regulatory standards. Experience with regulators and regulatory audits preferred.
  • Proficiency with project management tools, including MS Project, Excel, SharePoint and PowerPoint.
  • Skilled in leading multi-disciplinary teams including Engineering, Regulatory, Quality, Purchasing, Service, Production, in an FDA regulated environment.