NISI (Non-Invasive Surgical Innovations) is a Hong Kong-based MedTech business specialising in the development, manufacturing, and sales of surgical and diagnostic innovations.
Director of Engineering
Hong Kong
Job Description

  • Plan and direct all aspects of product engineering, production engineering, product commercialization and technical services
  • Ensure all engineering projects, initiatives, and processes are in compliance with the company's established policies and objectives
  • Develop and implement engineering strategy and strategic operational goals to exceed customer expectations for product development, quality, safety and efficacy
  • Work closely with CTO, internal and external key stakeholders, regulatory affairs, quality, customer service, manufacturing, sales and customers
  • Provide support to all on market device-related initiatives
  • Ensure all validation activities are conducted in line with regulatory and the company's requirements to meet business strategy and annual budgeting process
  • Assist in roadshows and participate in presentation to prospective investors


Candidates are expected to fulfill most of the following requirements:

  • Assist in roadshows and participate in presentation to prospective investors
  • 10+ years of product development/commercialization experience in an ODM setting, preferably on products requiring the integration of cross-discipline technologies, among high-precision multi-DoF mechanical drivetrains, real-time embedded control software, video systems and optic
  • 10+ years of marketing or product registration experience in the medical device industry
  • Must have in-depth understanding and application of GMP and ISO principles, concepts, practices and standards
  • Knowledgeable in relevant related regulatory requirements for commercialization of medical devices in markets such as China, India, United States and Europe
  • Proven ability to operate in matrix organization and work effectively with leadership, customers, and across geographic and organization boundaries
  • Excellent communication and people management skills
  • Must be fluent in English. Mandarin or Cantonese speaking is an added advantage


Primary Working Location:

  • Cyberport
  • Hong Kong


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