Senior Project Manager
Summary
The Senior Project Manager will lead cross-functional teams to manage medical device development projects from concept through commercialization, ensuring compliance with FDA and ISO quality standards. The role involves managing project schedules, risks, and budgets while coordinating with stakeholders to deliver hardware and software product solutions.
Job Title: Senior Project Manager
Location: Remote in North Carolina
Shift: 9am-5pm PST
Contract length: 6 months
Schedule: Fulltime, M-F
Pay: 72-75/hr
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.
Responsibilities/Essential Duties
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.
Experience 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.