Note: The job is a remote job and is open to candidates in USA. Mindlance is recruiting for a senior project management contractor to lead medical device development and sustaining projects. The role plans, executes, and commercializes software, hardware, and medical disposable projects while managing risks, schedules, budgets, governance, compliance, and cross-functional teams.
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
Skills
- 5+ years of experience
- Medical Experience
- 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
Benefits
- Remote work arrangement
Company Overview
Company H1B Sponsorship