About the role
Senior Project Manager – Medical Device Development
- Location: Remote – North Carolina
- Schedule: Full-time, Monday–Friday | 9:00 AM–5:00 PM PST
- Contract: 6 Months
About the Role
We are seeking a Senior Project Manager to lead complex New Product Introduction (NPI) and large sustaining projects within the medical device industry. This role will be responsible for planning and executing projects from concept through commercialization while managing scope, schedule, budget, resources, risks, and cross-functional accountability.
The Senior Project Manager will work closely with cross-functional teams, third-party organizations, and key stakeholders to ensure projects are delivered on time, within budget, and in compliance with applicable quality and regulatory requirements.
Key Responsibilities
- Lead medical device development projects from concept through commercialization.
- Analyze project risks, assess potential impact, and develop mitigation strategies.
- Identify, monitor, and manage critical path activities.
- Define project requirements and establish project work plans.
- Manage day-to-day project operations, scope, schedules, resources, and deliverables.
- Establish project governance structures to maintain alignment and accountability.
- Coordinate cross-functional teams, third-party organizations, and stakeholders.
- Develop project schedules, track progress, and communicate project status using project management tools.
- Drive accountability for project costs, schedules, scope, resources, and risks.
- Ensure compliance with Stage Gate processes, Quality Management System (QMS) requirements, and SOPs .
- Ensure project documentation meets Design History File (DHF) requirements and applicable regulatory standards.
- Identify and resolve team conflicts and communication challenges; escalate issues when necessary.
- Motivate cross-functional teams to achieve project objectives efficiently.
- Document lessons learned and share best practices across project teams.
- Perform other related duties as required by business needs.
Required Qualifications
- 5+ years of project management experience leading medical device development projects.
- Experience working within FDA Quality System Regulations (QSR) .
- Experience with CE Marking requirements .
- Experience working within ISO Quality Systems .
- Technical project management experience across software, medical disposables, and hardware product development .
- Strong experience managing cross-functional teams, project risks, schedules, and critical path activities.
- Ability to manage projects from development through commercialization.
Ideal Candidate
The ideal candidate combines strong project management expertise with hands-on experience in medical device product development, quality systems, and regulatory environments . This individual should be comfortable leading cross-functional teams, managing complex project dependencies, and driving projects through commercialization in a highly regulated environment.
Apply today to be considered for this Senior Project Manager opportunity.
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