Position overview
This position will directly report to Director of Engineering to lead the device improvements, the design control and risk management of our medical devise.
Key Duties and Responsibilities
• Contribute to cross-functional project(s) as engineering expert.
• Communicate with external manufactures to improve / develop the medical devices.
• Build strong relationship with external partners.
• Compliance with Quality Policy and regulations
Desired Education, Skills and Experience
• 3 + years Knowledge of relevant Medical Device industry.
• Knowledge of design control and risk management for Medical Device.
• Experience of through the product lifecycle of Medical Device including pre-market and post-market.
• Experience in the manufacture for medical devices.
• Experience in the creation of Quality Management System documents.
• Expertise in the mechanical design, polymer material and manufacturing engineering for medical devices are plus.
• Understanding of relevant regulations and guidelines, e.g. ISO13485, ISO9001, ISO14971 FDA 21 CFR Part 820.
• Very good communication and problem solution skill among global cross-functional team.
• Bachelor's Degree in Engineering or related discipline
• Strong Communication skill with external parties.
• Business level of English.
