Senior Medical Device Project Leader – NPI & Regulatory PM

haemonetics; Boston (MA); On-site; USD 90,000 - 153,000; Full time

Job summary

Haemonetics is seeking a Sr. Project Manager in the United States to plan, execute, and manage risk on NPI and large sustaining projects with strict deadlines and budgets.

You will coordinate resources across team members, vendors, and clients to deliver projects on plan. The role requires 5+ years in medical device project management, familiarity with FDA QSR, CE marking, and ISO quality systems, and experience across software, medical disposables, and hardware development.

Qualifications

• 5+ yrs in project management leading medical device development.
• Experience with medical device development under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems.
• Technical project management in software, Medical Disposables and hardware product development

Responsibilities

• Analyze project risks and identify their impact while developing mitigation strategies.
• Identify and manage critical path.
• Ensure appropriate project level definition across all stake holders and manage the project from concept to commercialization.
• Creates and executes project work plans and revises as appropriate to meet changing needs and requirements.
• Manages day-to-day operational aspects of a project and scope.
• Complies with the Stage Gate Process quality system and helps to enforce SOPs.
• Escalates appropriately when required. Mitigates team conflict and communication problems.
• Escalates appropriately when required. Motivates team to work together efficiently.
• Own and create appropriate levels of governance to ensure alignment and clear objectives
• Accountable for product compliance to design history file, regulatory standards, and QMS procedures
• Keeps track of lessons learned and shares those lessons with team members

Job description

Haemonetics is seeking a Sr. Project Manager in the United States to plan, execute, and manage risk on NPI and large sustaining projects with strict deadlines and budgets.

You will coordinate resources across team members, vendors, and clients to deliver projects on plan. The role requires 5+ years in medical device project management, familiarity with FDA QSR, CE marking, and ISO quality systems, and experience across software, medical disposables, and hardware development.