Mechanical Engineer II (Medical Devices)

Location: Shenzhen, China; in-office

Company

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

What you will do

• Design and develop parts, assemblies, enclosures, and subsystems for defibrillator and ventilator products.
• Create part drawings, assembly documents, bills of materials, purchasing specifications, and engineering change orders.
• Perform mechanics, thermal, flow, and tolerance analyses, including design of experiments and laboratory testing.
• Support risk assessments, design and process FMEA, regulatory documentation, and design history files.
• Lead or participate in technical design reviews, supplier evaluations, prototype builds, and troubleshooting investigations.
• Develop and execute verification, validation, test plans, and IQ/OQ/PQ protocols.

Requirements

• Bachelor of Science degree in Mechanical Engineering.
• 3–5 years of mechanical engineering and product design experience.
• Proficiency with SolidWorks, including part design and detailed drawings.
• Experience designing and documenting molded plastic housings, sheet metal, gaskets, PCBs, LCDs, cables, and labels.
• Working knowledge of ASME Y14.5 2009 drawing standards and strong written and verbal communication skills.
• Must work in-office in 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 in a product development organization focused on improving outcomes for patients with critical cardiopulmonary conditions.
• Collaborate with cross-functional engineering and science teams, suppliers, and regulatory stakeholders.
• Environment emphasizing innovation, self-motivation, entrepreneurship, and continuous improvement.
• Products and services used worldwide across EMS, hospital, public safety, and military markets.