Project Manager – Medical Device / Orthopaedics (Robotics, NPD, FDA Design Controls)

Job Title: Project Manager – Medical Device / Orthopaedics (Robotics, NPD, FDA Design Controls)

Job Summary

We are seeking an experienced Onsite Project Manager – Coordinator to lead complex new product development (NPD) programs in the medical device and healthcare life sciences space. This role is ideal for a seasoned program leader with deep experience in orthopaedics, robotics, electromechanical systems, and FDA-regulated product development. You will own end-to-end project execution — from concept to launch — while leading cross-functional teams across engineering, quality, regulatory, manufacturing, and commercial functions.

Position Details

• Location: Austin, TX – Onsite
• Domain: Healthcare / Life Sciences

Key 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 DevOps 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

Required Qualifications

• 10+ years of overall program/project management experience
• At least 5 years leading diverse projects in the medical device industry (orthopaedics preferred)
• Proven leadership of large, cross-functional programs in medical device / MedTech
• Experience with robotics, electromechanical systems, SaMD, MDDS, IoT, or connected systems
• Strong knowledge of FDA-regulated product development
• Bachelor's degree in engineering or a related discipline

Preferred / Key Requirements

• Education: Bachelor's or Master's degree in Biomedical, Mechanical, or related engineering field
• 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

Pay: $112,016.10 - $115,000.00 per year

Work Location: In person