Senior Principal Engineer (Medtech)

Location: Suzhou, Jiangsu, China; travel for assignments up to 50% of the time

Company

hirify.global develops vital organ therapy solutions, digital services, and advanced care technologies, with a long-standing focus on kidney care and dialysis.

What you will do

• Plan, establish, and qualify cross-functional production process automation and digitalization projects for manufacturing plants across the Asia-Pacific region.
• Support engineering design, facility and utility setup, equipment installation, commissioning, and qualification.
• Define project requirements and participate in the design, specification, and selection of critical equipment.
• Develop equipment URS, selection evaluations, process qualification protocols, reports, and plant SOP documentation.
• Provide technical direction to plant facility and utility teams while improving reliability, compliance, and cost performance.
• Oversee procurement, installation, commissioning, purchasing, and cost control for assigned automation and digital systems.

Requirements

• Bachelor’s degree in Automation or Process Control Engineering, Mechanical Engineering, or a related scientific discipline with at least 8 years of relevant experience; alternatively, a master’s degree with 5 years or a PhD with 3 years.
• Experience designing, developing, validating, and troubleshooting process automation and digitalization systems in GMP facilities.
• Technical competence across multiple engineering disciplines, including data analysis, data visualization, and reporting automation or standardization.
• Good understanding of GxP, Bioprocessing Equipment requirements, and Quality by Design principles.
• Proficient written and spoken English is required.
• Ability to prioritize multiple tasks, work effectively in a matrix organization, and travel for assignments up to 50% of the time.

Culture & Benefits

• Work within a mission-driven organization focused on improving patient lives through vital organ therapies.
• Collaborate across manufacturing plants and cross-functional engineering teams in the Asia-Pacific region.
• Contribute to regulated production environments governed by GxP requirements and corporate policies.
• Receive reasonable accommodation support during the application and interview process when needed.