Senior Medical Device Project Manager NPI and Regulatory

Haemonetics Software Solutions; Boston (MA); On-site; USD 90,000 - 153,000; Full time

Job summary

Haemonetics is seeking a Sr. Project Manager to plan, execute, and commercialize NPI and large sustaining projects within budget and deadlines. You will coordinate cross‑functional teams, manage risks, and ensure governance across costs, schedules, and scope.

With 5+ years in medical device project management and experience in FDA QSR, CE Marking, and ISO QMS, you will lead efforts to deliver complex projects while maintaining regulatory and quality standards.

Qualifications

• 5+ years of project management in medical device development.
• Experience with FDA Quality Systems Regulations (QSR), CE Marking, and ISO QMS.

Responsibilities

• Analyze project risks and mitigation strategies.
• Identify and manage the critical path.
• Define project scope acrossstakeholders and oversee from concept to commercialization.
• Create and execute project work plans and revise as needed.
• Manage day-to-day operational aspects of a project and scope.
• Comply with the Stage Gate quality system and SOPs.
• Escalate appropriately when required and resolve issues.
• Motivate the team to work efficiently and collaboratively.
• Leverage PM tools to maintain schedule and status reporting.
• Create governance to ensure alignment and clear objectives.
• Ensure product compliance to design history file, regulatory standards, and QMS.
• Capture and share lessons learned with the team.

Skills

Risk management

Cross-functional leadership

Regulatory compliance

Schedule management

Job description

Haemonetics is seeking a Sr. Project Manager to plan, execute, and commercialize NPI and large sustaining projects within budget and deadlines. You will coordinate cross‑functional teams, manage risks, and ensure governance across costs, schedules, and scope.

With 5+ years in medical device project management and experience in FDA QSR, CE Marking, and ISO QMS, you will lead efforts to deliver complex projects while maintaining regulatory and quality standards.