ProductDevelopmentEngineer

This role involves working on various aspects of product development, including design quality, mechanical engineering, electrical and electronics engineering, and software engineering.

As a Research and Development Engineer, you will be responsible for creating a quality culture by driving compliance activities around specific products or regions. This includes ensuring quality and regulatory compliance while driving process effectiveness and efficiency.

Experience in medical device QMS processes is essential, as well as the ability to organize and drive rigorous compliance of QMS processes at a medical device facility.

You will also be responsible for communicating complex messages, negotiating with others, and making decisions that impact site compliance.

In addition, you will ensure process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process-related documentation.

Required qualifications include a minimum of a bachelor's degree, experience in establishing design quality control, assurance, regulatory affairs teams, and competence development from scratch within a regulated industry.

Proficiency in English, both written and oral, is also essential, as well as experience in understanding and interpreting risk management, design controls, standards, and regulations for Class 2 and Class 3 devices.