Research and Development Manager (Medical Device)
About this position
Responsibilities
• Leading R&D team on new product development and/or integration programs supporting execution of the company business strategic plan
• Collaborating with sales team to develop specifications for new products that align with customer needs
• Creation and communication of project reports, analyses and presentations for cross-functional project management
• Manage the readiness of information/tooling related to new product development per ISO13485 design control requirement such as BOM, WI, artwork, design history file (DHF), risk assessment, standard labor time including product training to ensure the readiness before transfer new product to mass production
• Development and design product prototype and packaging
• Prepare documents in accordance with regulatory requirement for product registration
• Research product design and material study for new product development
• Improvement initiative for cost reduction, design and process improvement
Requirements
• At least 5 years experienced in management level as R&D engineer, NPI or related field
• Experience with medical device surgical gown, drape would be an advantage
• Having knowledge in ISO13485 standard
• Good communication skills in English
• Able to work well under pressure and handle multiple tasks with deadline
• Understand design drawing and dimensional tolerance
• Good skill in MS Office, excel (Pivot & Vlookup), powerpoint
• Leadership skill with collaborative attitude
• Can-do attitude