NISI (HK) Limited, a premier surgical robotic start-up based in Hong Kong, is looking for high-caliber candidates to make significant contributions to their product development and manufacturing roadmap.
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:
Masters in Engineering or related technical field (electrical, electronics, mechanical, mechatronics and/or computer science). A PhD or MBA degree is an added advantage
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.
Candidates with lesser experience may be considered for the position of Assistant Director of Engineering.
Salary will be commensurate with qualifications and experience. To apply, please send email to email@example.com with the post you are applying; your resume including personal particulars, employment history, current and expected salary, contact phone number and availability. All personal data collected will be used for recruitment purpose only.