Medical Device : R&D Manager

【Client Description】

Our client is a reputable medical device manufacturer with a solid footprint in Taiwan. Known for its product quality, regulatory discipline, and engineering capabilities, the company is committed to advancing its R&D operations to drive innovation, clinical value, and sustained market growth.

【Candidate Profile】

• Bachelor’s degree or above in Biomedical Engineering, Mechanical Engineering, Material Science, or related disciplines.
• 8+ years of experience in medical device product development, with at least 3 years in a supervisory or project leadership role.
• Solid knowledge of design control, risk management, and DHF documentation under ISO 13485 and QMS frameworks.
• Hands-on experience in product verification & validation, prototyping, and transfer to manufacturing.
• Familiarity with TFDA regulations and regulatory documentation requirements.
• Strong project management, cross-functional coordination, and team leadership capabilities.
• Excellent communication skills in Mandarin; English proficiency is a plus.

【Responsibilities】

The R&D Manager will be responsible for leading the research and development team in new product development, design optimization, and cross-functional collaboration to support product lifecycle management and market expansion strategies. Key responsibilities include:

• Lead and manage the R&D team in project planning, execution, and resource allocation.
• Drive new product development from concept through design verification and validation, ensuring compliance with design control procedures.
• Collaborate closely with RA, QA, Manufacturing, and Marketing teams to align technical feasibility with regulatory and market needs.
• Ensure timely documentation of DHF, DMR, DHR and related technical files per ISO 13485 and internal QMS.
• Evaluate and manage external suppliers or partners involved in product development.
• Lead design reviews, risk assessments, and design changes based on feedback from clinical users or post-market data.
• Monitor technology trends, propose innovative solutions, and support intellectual property development.