R&D Director

Agilis Robotics Limited; Hong Kong; On-site; HKD 900,000 - 1,300,000; Full time

Job summary

Agilis Robotics Limited seeks a highly qualified professional to lead design planning and develop a robust quality management system for medical devices. The role spans design reviews, risk analyses, validation, and resolving product-related issues while ensuring regulatory compliance across the organization.

The successful candidate will coach stakeholders to meet QMS requirements, handle ad hoc regulatory initiatives, and thrive in a fast-paced, evolving environment with travel to facilities

Qualifications

• PhD academic background is required.
• Knowledge in ISO 13485 requirements.
• Strong technical background with the ability to understand engineering concepts.
• Fluent in English and Cantonese; Mandarin a significant plus.

Responsibilities

• Plan and monitor design and development of the product.
• Quality management system setup and implementation.
• Perform product design review, risk analysis, validation, or solutions on any issues related to the product/parts, process, equipment, or tools as appropriate.
• Coach Company stakeholders to fulfil the medical QMS and regulatory requirements.
• Ad hoc assignment related to new medical device regulations, customer requirements, corporate initiatives, or strategic programs

Skills

Engineering concepts

Team spirit

Problem solving

Interpersonal skills

Communication

Ability to work under pressure

Education

PhD

Job description

• Plan and monitor design and development of the product.
• Quality management system setup and implementation.
• Perform product design review, risk analysis, validation, or solutions on any issues related to the product/parts, process, equipment, or tools as appropriate.
• Coach Company stakeholders to fulfil the medical QMS and regulatory requirements.
• Ad hoc assignment related to new medical device regulations, customer requirements, corporate initiatives, or strategic programs

Job Requirements:

• Preferred at least 10 years of working experience and 5 years of research experience.
• Responsible for planning and monitoring the design and development of the product and building quality management system.
• PhD academic background is required.
• Professional fluency in spoken and written English and Cantonese (Mandarin is a significant plus).
• Knowledge in ISO 13485requirements.
• Strong technical background with the ability to understand engineering concepts.
• Strong team spirit and ability to work under pressure.
• Good problem solving, interpersonal skills, and able to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization and external parties.Willing to travel to production facilities and vendors in China or overseas.

We offer an attractive remuneration package including competitive salary, 5-day work and annual leave.

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