Onsite Project Manager- Co-ordinator

Responsibilities

• Lead and deliver complex NPD programs involving robotics, electromechanical systems, embedded software, and cloud applications.
• Own project execution including schedule, budget, risk management, and issue resolution.
• Form and lead cross‑functional teams across engineering, quality, regulatory, manufacturing, and commercial functions.
• Apply Agile and Dev Ops best practices for software and system development.
• Oversee cloud‑based and connected digital solutions in a regulated medical device environment.
• Ensure compliance with design controls, QMS requirements, and medical device regulations.
• Support Design History Files (DHF) and Phase Review governance.
• Provide clear executive‑level reporting on project status, risks, and opportunities.
• Partner with Franchise and Commercial leadership to shape product pipeline and commercialization strategy.
• Facilitate design reviews, requirements reviews, vendor meetings, and cross‑functional forums.
• Drive the development lifecycle of orthopaedic products from concept to launch.
• Develop detailed project plans, schedules, and budgets, setting timelines for design, verification, and validation.
• Manage sustaining engineering activities, including improvements, enhancements, and design changes.
• Lead cost‑reduction initiatives while maintaining quality and safety standards.
• Monitor and manage RAID logs (risks, assumptions, issues, dependencies).
• Act as primary point of contact for stakeholders, ensuring regular communication and reporting.
• Coordinate onsite/offsite teams, allocate resources, and ensure timely task execution.

• Education: Bachelor’s or Master’s degree in Biomedical, Mechanical, or related engineering field.
• Experience: 10+ years overall, with at least 5 years leading diverse projects in the medical device industry (orthopaedics preferred).
• Certifications: Project Management certification (PMP, PRINCE2, or Agile PM).
• Technical
  
  Skills:
  
  Proficiency in MS Office, project management tools, and CAD/design documentation.
• Domain Knowledge: Strong understanding of medical device design controls (21 CFR 820.30).
• Soft Skills: Excellent communication, proactive problem‑solving, and ability to thrive in fast‑paced environments.

• 10+ years of program/project management experience.
• Proven leadership of large, cross‑functional programs in medical device/Med Tech.
• Experience with robotics, electromechanical systems, SaMD, MDDS, IoT, or connected systems.
• Strong knowledge of FDA‑regulated product development.
• Bachelor’s degree in engineering or related discipline.