Sr Program Manager
6 Tech Drive Greater Boston area, Massachusetts 01810
Position Title: Sr. Program Manager
Job Location: Greater Boston Area
Interview Expectations: Phone/In Person Required
Required: Med Device, project management, program management. Looking for stellar, polished candidates.
This individual is responsible for managing programs consisting of product development and/or sustaining projects within the Program Management Office.
- Responsible for overall project planning, execution, and closure to achieve the program/project objectives (scope, schedule, cost, quality).
- 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 Management.
- Responsible for the project DHF and other required documentation.
- Manages program and project risk (risk identification and mitigation).
- Collaborates with Department Managers regarding resource planning, schedules, budgets, and quality of deliverables.
- Contributes to program planning, strategic planning, budgeting, and process improvement initiatives.
- Ensures compliance to internal SOPs and QMS and FDA and other industry regulations.
- Performs other duties as needed and assigned.
- BS in Engineering (ME/EE/SW/Biomedical/Systems); prefer MS.
- Medical devices background / education preferred
- 10+ years in the development of complex embedded systems, PC-based products and/or electro-mechanical systems or devices
- 5+ years project management in a cross-functional environment
- Medical device experience is preferred
Special Competencies or Certifications:
- PMP Certification
- Earned value methodology of reporting
- 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
- Proficiency with project management tools, including MS Project, Excel and PowerPoint
- Skilled in leading multi-disciplinary teams including Engineering, Regulatory, Quality, Purchasing, Service, Production, in an FDA regulated environment