Location: Gyeonggi-do
Contract Type: Permanent
Salary: ₩50,000,000 – ₩70,000,000 per annum
An international medical device company is seeking a Project Manager. The chosen applicant will lead the development and execution of medical devices, including surgical robotics and microcatheter systems.
Responsibilities:
- Drive project planning and check schedules for execution across hardware, software, clinical, and regulatory domains for Class II or III surgical robotics and microcatheter devices
- Manage complex system integration efforts, including robotic actuation, embedded control, haptics, and navigation components
- Help ensure all projects meet design control standards per FDA 21 CFR Part 820, ISO 13485, and IEC 60601 or IEC 62304 for electromechanical and software-driven systems
- Report project progress, KPIs, and risk status to executive leadership; coordinate deliverables with external partners, suppliers, and contract manufacturers
- Partner with clinical and regulatory teams to prepare for first-in-human trials, pre-submissions, and eventual FDA clearance or approval route
Requirements:
- Bachelor’s degree or above in engineering, bioengineering, or related technical discipline
- More than 2 years of project or program management experience in medical devices (robotics, catheters, or interventional platforms is preferred)
- Experience with design reviews, DHF maintenance, and cross-functional stage-gate development
- Understanding of robotic actuation and electromechanical systems integration
- Familiarity with IEC 60601, IEC 62366, ISO 14971, and risk file development
- Proficient in MS Project, Smartsheet, Jira, or other tracking tools
- Experience supporting first-in-human studies and early clinical evaluations is preferred
- Background in endovascular, neurovascular, or interventional cardiology product development is preferred
- Exposure to robotic systems with software, sensing, and haptic feedback components is preferred
- Possess a valid PMP, Agile Scrum Master, or similar certification is a plus
About the Company:
Based in the United States, this international medical device company specialises in the development of innovative endovascular robotic systems.