GForce Life Sciences
Project Manager
12-month contract
Onsite in Newton, MA
Key Responsibilities:
- Plan and directly manage cross-functional projects, including coordination with external resources and contracted companies
- Develop comprehensive project plans in collaboration with program managers, senior leadership, and stakeholders
- Partner with development team members to ensure accountability for project tasks and deliverables
- Manage project budgets, prepare financial forecasts, and track actuals against projections
- Monitor project progress and implement corrective actions or contingency plans to meet key milestones and deliverables
Required Qualifications:
- Bachelor’s degree in Engineering, Computer Science, or a related discipline
- 5–10 years of project management experience in medical device product development, from concept to commercialization
- Experience managing either:
- New product introduction or design transfer to manufacturing, or
- Verification and validation activities traced through needs and requirements
- Strong knowledge of FDA Quality System Regulation (21 CFR 820) and EU Medical Device Regulation
- Proficiency managing DHR (Device History Record) tracked deliverables such as incoming inspection, configuration management, and in-line inspection
- Demonstrated success in managing development changes prior to commercial release
- Willingness to travel up to 10%, as needed