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Senior R&D Project Manager
Not specifiedFull-timeProject ManagementMedical Devices
Lead Class III medical device research and development projects from concept development through product launch in a highly regulated environment.
Responsibilities
- Lead Class III R&D projects from concept development through product launch
- Develop project timelines, milestones, scope, schedules, and budgets
- Build and coordinate cross-functional project teams, including non-direct reports
- Manage design-controlled product development and define testable product requirements
- Lead design reviews, verification, validation, testing, and analysis activities
- Monitor regulations, standards, internal procedures, and project compliance
- Coordinate interdepartmental meetings and resolve project issues
- Track deliverables and communicate project status to stakeholders and management
- Escalate risks and concerns through appropriate management channels
- Ensure quality, performance, cost, schedule, and revenue deliverables are achieved
Requirements
- Bachelor’s degree in Mechanical or Biomedical Engineering
- At least 5 years of industry experience, including 2 years managing projects
- Experience with product development processes in the regulated medical device industry
- Experience coordinating cross-functional teams and integrating scope, responsibilities, specifications, timelines, and resources
- Experience with verification and validation of FDA-cleared devices
- Experience with design of experiments, statistical analysis, and data analysis tools
- Experience working in an FDA-regulated development environment, particularly under ISO 13485
Nice to have
- Experience with interventional medical devices