Research and Development Project Manager

We are actively seeking an experienced R&D Project Manager with a strong background in Medical Device New Product Development (NPD) to support enterprise-level R&D initiatives within a highly regulated healthcare environment.

The ideal candidate will have hands‑on experience driving products through the full medical device development lifecycle — from design inputs and verification/validation through regulatory submission and product launch.

• Strong Medical Device NPD experience
• Deep understanding of Design Controls
• Experience supporting FDA 510(k), MDR, and regulatory submissions
• Ability to work in fast-paced, ambiguous R&D environments
• Proven success driving cross‑functional alignment across R&D, Regulatory, Quality, Operations, and Supply Chain
• Experience supporting product launch and sustaining engineering activities
• Lead complex R&D and New Product Development programs in FDA‑regulated environments
• Drive project execution from concept through commercialization
• Manage project schedules, budgets, resources, risks, and deliverables
• Coordinate cross‑functional teams including Regulatory Affairs, Quality, Manufacturing, Operations, Marketing, and Supply Chain
• Support design control activities including product performance, assembly integrity, product safety, labeling, packaging, and verification/validation efforts
• Partner with stakeholders to define project scope, validation strategy, and requirements in evolving development environments
• Ensure projects remain compliant with FDA, ISO 13485, GMP, and MDR requirements
• Provide executive-level status reporting and project communication
• 4+ years of Project Management experience within Medical Devices or regulated healthcare industries
• Experience with Design Controls and Medical Device Development Lifecycle
• Strong understanding of NPD processes and regulatory requirements
• Proficiency with MS Project, Excel, PowerPoint, SharePoint, and related PM tools

This is an excellent opportunity for someone who thrives in early‑stage product development environments and can independently drive execution across multiple teams.

Interested candidates can apply directly or send resumes for immediate consideration.