百特医疗设备（苏州）有限公司
AD of Value Engineering
医疗设备/器械
经营管理类
上海
10年以上
本科
¥6 - 10K14薪
职位描述
Key Responsibilities
Lead value engineering and localization projects for core components/subsystems of active medical devices, covering opportunity identification, technical breakdown, solution evaluation, sample verification, and mass production introduction.
Develop project roadmaps, milestones, and value delivery targets around cost optimization, functional equivalence, quality compliance, supply continuity, and mass production feasibility.
Collaborate with procurement, supply chain, manufacturing, quality, regulatory/compliance, and global R&D teams to drive cross-functional decision-making, problem solving, and project closure.
Evaluate and develop local suppliers, translating R&D design requirements into engineering and process solutions that suppliers can execute, verify, and scale to production.
Establish and lead structured design transfer from R&D to suppliers, ensuring design intent, critical requirements, specifications, drawings, test expectations, and quality controls are clearly translated, documented, and implemented at the supplier site.
Partner with suppliers and internal quality/manufacturing teams to ensure engineering product quality during development, verification, design transfer, and production introduction, including risk mitigation, issue resolution, process capability assessment, and readiness for compliant production.
Deeply engage in sample development and engineering verification by providing drawing interpretation, process optimization, DFM/DFA recommendations, and technical risk assessment to improve first-sample success rate and introduction efficiency.
Establish standard processes, evaluation templates, supplier assessment models, and project KPIs for value engineering and localization projects, building repeatable local engineering capabilities.
Act as an individual contributor in the short term while leading cross-functional virtual teams; as the project scope expands, participate in building and developing the local value engineering team.
职位要求
Qualifications
Bachelor’s degree or above in mechanical design, mechatronics, automation, electrical engineering, electronics, precision instruments, biomedical engineering, or a related engineering discipline.
8–15 years of relevant work experience, including at least 5 years in the medical device industry; experience with active medical devices, mechatronic equipment, or complex engineering products is preferred.
Successful track record in medical device value engineering, supplier substitution, localization, or product lifecycle cost optimization.
Experience in R&D, NPI, process/manufacturing engineering, supplier technical development, value engineering, cost optimization, or localization projects.
Familiar with the development, manufacturing, verification, and mass production introduction processes for mechanical structural parts, electronic components, mechatronic assemblies, or core components of active medical devices.
Experience in supplier technical assessment, sample development, process optimization, DFM/DFA, verification and validation, and production transfer, with the ability to drive suppliers to meet design, quality, compliance, and cost targets.
Demonstrated experience in manufacturing transfer of design, including establishing process controls, manufacturing readiness criteria, critical-to-quality parameters, and production documentation to ensure final unit quality, repeatability, and compliance.
Familiar with medical device R&D, design control, design change, supplier introduction, verification and validation, and quality system requirements; knowledge of ISO 13485 is preferred.
Understanding of electronic hardware, embedded systems, firmware/software, or active medical device system architecture will be a plus.
Strong project management, cross-functional collaboration, and stakeholder management skills, with the ability to drive alignment and decision-making among global R&D, local supply chain, manufacturing, quality, regulatory/compliance, and suppliers. Team management experience is a plus.
Fluent in English, with the ability to communicate technical topics, deliver project updates, and drive key issues with overseas R&D teams and global stakeholders.
Willing to travel at a certain frequency depending on supplier locations and project stages.
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