Medical Device Research and Development Manager / Director 醫療器材研發經理 LSMD_662
Posted Updated 3
views
Description
- Manage and mentor a team of engineers, scientists, and designers in the development of innovative medical devices and consumables.
- Oversee the design, prototyping, and testing of medical consumables and equipment, ensuring products meet functional, regulatory, and user requirements.
- Ensure that all products comply with relevant industry regulations and standards (e.g., FDA, CE Marking, ISO 13485).
- Lead cross-functional project teams to ensure timely delivery of product development milestones and manage the full lifecycle of product development from initial concept through commercialization.
- Work closely with clinical, quality assurance, marketing, and manufacturing teams to bring new products to market.
- Drive the innovation of new technologies and improvements to existing products, ensuring they are competitive and meet the evolving needs of healthcare providers and patients.
- Identify and mitigate technical risks, ensuring the development process remains efficient and compliant.
- Ensure all necessary technical documentation, design history files (DHF), and risk management files are properly maintained and updated.
- Understand market trends, customer needs, and emerging technologies to inform product development strategies.