Senior Mechanical Engineer

Qualifications

• Required Skills and Experience • Strong understanding of design for reliability, robustness, and manufacturing. • Proficiency using CAD to design and document mechanisms; SolidWorks preferred • Self-motivated, hands-on, and the ability to work well within a fast-paced team-oriented environment. • Strong analytical and problem-solving skills, with experience leveraging engineering tools and methodologies to drive design excellence. • Ability to handle ambiguity and adapt to changes effectively an
• Working Conditions • Ability to travel up to 10% of the time. Preferred Skills and Experience • Knowledge of China regulatory requirements, technical guidelines, and medical device submission pathways; experience navigating the China regulatory landscape is highly preferred. • Hands-on experience with hardware compliance testing, including IEC 60601 and related medical device standards. • Knowledge of pre-clinical and clinical study strategies for medical devices, including planning, execution,