Description

You will lead complex New Product Development programs for robotics, electromechanical systems, and connected solutions in regulated environments.

Responsibilities

• Manage project execution including schedule, budget, risks, and issues across cross-functional teams.
• Apply Agile and DevOps practices to drive product lifecycle from concept to launch.
• Oversee cloud-based and embedded software solutions while ensuring compliance with design controls and QMS.
• Support Design History File (DHF) and phase review processes for FDA-regulated medical devices.
• Provide executive-level reporting and manage sustaining engineering enhancements.

Required Skills

• 10+ years in program or project management, with 5+ years in medical device leadership.
• Experience with robotics, electromechanical systems, IoT, or connected systems.
• Strong understanding of FDA-regulated product development and 21 CFR 820.30 design controls.
• Proficiency in MS Office and standard project management tools.
• Bachelor’s or Master’s degree in Biomedical, Mechanical, Engineering, or related field.
• PMP, PRINCE2, or Agile PM certification preferred.
• Ability to coordinate teams, manage resource allocation, and maintain RAID logs.

Key Skills

Education

Bachelor’s/Master’s degree