Staff NPI Manufacturing Engineer (Life Sciences)

Location: Suzhou, Jiangsu, China; onsite

Company

hirify.global develops science and technology solutions that help customers address complex challenges across life sciences and related fields.

What you will do

• Lead manufacturing and supply chain design transfer for flow instruments, subsystems, software-enabled workflows, reagents, and consumables from feasibility through production release.
• Represent Operations and Supply Chain in cross-functional teams and translate customer, application, and manufacturing needs into product, system, software, serviceability, and manufacturability requirements.
• Own factory NPI deliverables, execution plans, readiness reviews, design transfer reviews, manufacturing processes, work instructions, layouts, MBOMs, and DMR/DHR content.
• Lead process risk assessment and validation activities, including pFMEA, test-method validation, equipment qualification, and IQ/OQ/PQ/PPQ process validation.
• Optimize instrument performance testing, calibration, reagent and chemical preparation, shop-floor workflows, quality, stability, cycle time, and operating efficiency.
• Coordinate prototype and pre-production builds, root-cause analysis, corrective actions, design reviews, production ramp, early-life stabilization, and knowledge transfer across sites.

Requirements

• Degree in mechanical, electrical, automation, biomedical, manufacturing, industrial, chemical engineering, or a related technical field.
• Bachelor’s degree with 9+ years of experience, master’s degree with 7+ years, or doctoral degree with 4+ years.
• Required experience leading NPI design transfer for complex systems or instruments and coordinating global cross-functional teams.
• Hands-on experience with system and instrument performance testing, calibration, test-method development and validation, equipment qualification, and manufacturing process validation.
• Strong knowledge of design control and quality management systems, especially design transfer, design change, production and process control, and purchasing control.
• Professional communication in both English and Chinese with engineering, operations, quality, supply chain, and leadership stakeholders is required.

Nice to have

• Experience with life-science, medical-device, or IVD products.
• Knowledge of flow cytometry, reagent or chemical handling, software-enabled manufacturing workflows, and data-driven acceptance testing.
• Project management, Lean, Six Sigma, or quality-related certification.

Culture & Benefits

• Cross-functional collaboration with R&D, Quality, Service, Materials and Planning, Sourcing, and Production.
• Opportunity to coach production associates and less-experienced engineers.
• Work with global standard work and support knowledge transfer across manufacturing sites.
• Substantial autonomy within functional policies, with influence across multiple functions, sites, and product programs.