Remote Sr. NPI Project Manager – Medical Devices

Techtrueup; Boston (MA); On-site; USD 110,000 - 165,000; Full time

Job summary

Techtrueup in the United States is seeking a Senior Project Manager to lead medical device development programs, spanning software, disposables, and hardware, with strict adherence to FDA QSR and ISO quality standards.

You'll drive cross-functional teams, manage risk, timelines, and budgets, and ensure Stage Gate compliance while delivering new products from concept through commercialization.

Remote work with EST availability for 6+ month engagements, with potential for extension.

Qualifications

• 5+ years of project management experience leading medical device development projects.
• Experience with FDA Quality System Regulations, CE Marking, and ISO Quality Systems.
• Technical PM 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 SOPs.
• Identify and resolve team conflicts and communication issues; elevate 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

Project management

Risk management

Cross-functional leadership

Regulatory compliance

Job description

Techtrueup in the United States is seeking a Senior Project Manager to lead medical device development programs, spanning software, disposables, and hardware, with strict adherence to FDA QSR and ISO quality standards.

You'll drive cross-functional teams, manage risk, timelines, and budgets, and ensure Stage Gate compliance while delivering new products from concept through commercialization.

Remote work with EST availability for 6+ month engagements, with potential for extension.