Senior System Engineer (MedTech)

Location: Suzhou, Jiangsu, China

Company

hirify.global partners with customers worldwide to develop science and technology solutions for complex challenges.

What you will do

• Provide system-level support for customer-feedback cases and help the Sustain Team analyze and identify root causes.
• Support design changes for legacy products by evaluating system impacts and risks, creating design test protocols, and maintaining the Design History File.
• Lead product safety risk management and create safety and regulatory requirements in Design Inputs.
• Support designers and testers in interpreting and testing standards and regulations applicable to product design.

Requirements

• Engineering and technology background with R&D experience in IVD or medical-equipment products.
• Bachelor’s degree in a relevant field with 5+ years of experience, or a master’s degree with 3+ years of experience.
• Proficiency in system engineering, including at least one of dFMEA, risk management, or integration testing.
• Strong capability in at least one area: mechanical engineering, electronics, or embedded software.
• Strong problem-solving skills for analyzing complex issues.
• Proactive learning ability and willingness to acquire new knowledge.

Nice to have

• Knowledge of product safety standards such as IEC 60601.
• Knowledge of quality management standards such as ISO 13485.

Culture & Benefits

• Full-time employment in Suzhou, Jiangsu, China.
• Work contributes to solutions designed to increase the real-life impact of science and technology.