Senior Project Manager - Medical Device / Combination Products
Location : Valley Forge PA US 19481
Job Type : Temp/Contract
Reference Code : 20145-BZ1
Compensation : open - 50-60/h
Start Date : 02/28/2020
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Contract position for a Senior Project Manager to lead the development of Combination Products of medical devices with drug delivery systems, including initiation, planning, execution, monitoring and closure of projects.
- Lead Core Project Team (CPT) and be an active participant at associated team meetings (including expert teams and Project strategy groups).
- The Senior Project Manager will be responsible for securing the appropriate functional resources for the project team(s) and maintaining well functioning core project team(s).
- Oversees the collaboration activities with external partners in the integration of services, technologies and capabilities to ensure delivery of project (where relevant).
- Involvement in commercial/licensing/partnering/intellectual property activities related to the project(s) and/or program.
- The Senior Project Manager will need to ensure contractual terms are adhered to.
- Responsible for providing critical inputs into the business planning process.
- Key project activities and costs are expected to be estimated, tracked and managed for each cost center to support Research & Development executives in planning and prioritization of resources and projects.
- Represent the site Head of Project Management at major meetings (as required).
- Actively support and role model expected behaviors and practices rolled out by the Project Management Leadership Team (PMLT) designed to improve the performance of the team (project and Global Project Management group).
- Actively participate and may lead the implementation of new processes and process improvement initiatives designed to improve the efficiency and effectiveness of the Project Management Department or the Research & Development division.
Required Qualifications :
- BS / MS degree in Engineering or Biotechnology.
- Minimum 5 years experience in the medical device or biotechnology industry with preferred experience in Combination Products.
- Minimum 5 years experience in managing medical device development projects, including those with complex technical, geographic, and/or regulatory elements.
- In-depth knowledge in medical device development and manufacturing processes preferably in drug delivery systems with strong knowledge of FDA 21CFR820 and ISO 13485.
- Knowledge of 21CFR Part 3 and part 4 a plus.
- Experience with global project teams and/or has demonstrated experience in leading cross functional project teams in a matrix environment.
- Experience with process and systems improvements and change initiatives.
- Demonstrated experience in strategic planning and decision analysis.
- Has expertise in all phases of Project Management, Initiation, Planning, Execution, Monitor/Control, Closeout.
- Demonstrated experience in developing, managing and controlling cross functional project budgets, timelines and scope documents.
Contact: Bill Zukowsky