Mechanical Engineer II (Medical Devices)

Location: Shenzhen, China

Company

Develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, including defibrillators, ventilators, AEDs, trauma kits, and temperature management solutions.

What you will do

• Design and develop parts, assemblies, enclosures, and subsystems for new and revised defibrillator and ventilator products.
• Create part drawings, assembly documents, bills of materials, purchasing specifications, and engineering change orders.
• Perform mechanical, thermal, flow, tolerance, and statistical analyses, along with design of experiments and laboratory testing.
• Develop test plans and validation protocols, and conduct verification and validation testing with complete documentation.
• Support risk assessments, design and process FMEAs, regulatory submissions, design history files, and production release activities.
• Lead or participate in design reviews, supplier evaluations, troubleshooting, root-cause investigations, product complaint resolution, and CAPA activities.

Requirements

• Bachelor of Science in Mechanical Engineering.
• 3–5 years of mechanical engineering and product design experience.
• Proficiency with SolidWorks, including part design and detailed drawings.
• Working knowledge of ASME Y14.5 2009 drawing standards and experience designing embedded-system packaging components such as molded plastics, sheet metal, gaskets, PCBs, LCDs, cables, and labels.
• Strong written and verbal communication skills, self-motivation, and the ability to work with minimal oversight.
• Work location: Shenzhen, China.

Nice to have

• SolidWorks CSWP certification.
• Experience in medical devices or another highly regulated industry.
• Working knowledge of IEC 60601, FDA, GMP, and ISO 13485:2003.
• Experience with SolidWorks PDM and Simulation.

Culture & Benefits

• Work focused on improving outcomes for patients with critical cardiopulmonary and respiratory conditions.
• Environment emphasizing innovation, self-motivation, continuous improvement, and entrepreneurial thinking.
• Products and services supporting EMS, hospitals, public safety, and military customers worldwide.