Global Value Engineering Lead, R&D (Medical Devices)

Location: Shanghai, China; onsite role with travel to supplier locations as required

Company

hirify.global develops vital organ therapy solutions, including digital and advanced services for kidney care and dialysis.

What you will do

• Own the global value engineering strategy, savings commitments, and execution for the electromechanical peritoneal dialysis cycler.
• Identify and prioritize opportunities across product design, cost structure, manufacturing, sourcing, supply chain, and lifecycle cost.
• Coordinate China execution teams with global R&D, Quality, Regulatory, procurement, supply chain, manufacturing, finance, and suppliers.
• Drive critical component and sub-assembly localization while maintaining design history files, design controls, risk management, quality, safety, reliability, and regulatory compliance.
• Evaluate and develop local suppliers, contract manufacturers, and component vendors, and lead sample development, verification, design transfer, and manufacturing readiness.
• Lead Supplier Development Engineers and Supplier Quality Engineers while establishing global value engineering standards, cost-lever frameworks, governance routines, templates, and KPIs.

Requirements

• Master’s degree or higher in mechanical design, mechatronics, automation, electrical engineering, electronics, precision instruments, biomedical engineering, or a related engineering discipline.
• 12–15 years of relevant experience, including at least 10 years in the medical device industry; experience with active medical devices, mechatronic equipment, or complex engineering products is preferred.
• Successful experience leading VAVE or redesign-for-cost projects with demonstrated COGS and end-to-end savings of 40% or more.
• Deep knowledge of Core Cost Levers and integrated value engineering across product architecture, design, materials, components, manufacturing, sourcing, supply chain, quality, and lifecycle cost.
• Deep knowledge of the China medical device supply chain, supplier ecosystem, and manufacturing capabilities.
• Hands-on experience with ISO 13485, FDA 21 CFR Part 820, ISO 14971, and NMPA requirements.
• Experience with development, manufacturing, verification, and mass production introduction for mechanical parts, electronic components, mechatronic assemblies, or active medical device components.
• Experience in supplier technical assessment, sample development, process optimization, DFM/DFA, verification and validation, manufacturing transfer, process controls, critical-to-quality parameters, and production documentation.
• Full professional proficiency in spoken and written Mandarin Chinese and English is required.
• Ability to influence and lead cross-functional teams across geographies, cultures, and time zones; project management skills are required.

Nice to have

• Understanding of electronic hardware, embedded systems, firmware/software, or active medical device system architecture.
• PMP or Lean Six Sigma Black Belt certification.

Culture & Benefits

• Mission-driven work focused on extending lives and expanding possibilities for patients and care teams.
• Collaboration across global R&D, quality, regulatory, operations, and supplier organizations.
• Travel is required at a frequency determined by supplier locations and project stages.
• Reasonable accommodations are available for qualified individuals with disabilities during the application and interview process.