NPI Project Manager - Medical Device

Techtrueup•Boston, MA

4d•Remote

About The Position

The Sr. Project Manager is responsible for planning, executing, managing risk, overseeing critical path activities, and commercializing NPI and large sustaining projects within established deadlines and budgets. This role engages resources and coordinates cross-functional teams, third-party organizations, and stakeholders to successfully deliver projects according to plan. The position is accountable for establishing project governance and driving cross-functional accountability for costs, schedules, scope, resources, and project risks. The incumbent may be asked to perform other related duties as required by business needs.

Requirements

5+ years of project management experience leading medical device development projects.
Experience working within FDA Quality System Regulations, CE Marking requirements, and ISO Quality Systems.
Technical project management experience involving software, medical disposables, and hardware product development.

Responsibilities

Analyze project risks, assess impact, and develop mitigation strategies.
Identify and manage critical path activities.
Define project requirements and lead projects from concept through commercialization.
Create and execute project work plans and adjust them as business needs change.
Manage day-to-day project operations and scope.
Ensure compliance with Stage Gate processes, QMS requirements, and standard operating procedures (SOPs).
Identify and resolve team conflicts and communication issues; escalate when necessary.
Motivate cross-functional teams to achieve project objectives efficiently.
Utilize project management tools to develop schedules, track progress, and report status.
Establish governance structures that ensure alignment and clear objectives.
Ensure compliance with design history file requirements, regulatory standards, and quality management system procedures.
Document lessons learned and share best practices across teams.