职位描述
his role sits at the critical interface between our overseas clients and our internal R&D, production, and quality teams. You will directly manage a client's dedicated product development team, translating client technical requirements and expectations into actionable engineering plans, while ensuring our factory-side execution (PCB design, optical/LED systems, mechanical/silicone tooling, and QA testing) meets spec, cost, and timeline targets.
Key Responsibilities
•Team & Project Management: Lead and manage the client's product development team (engineers, PMs), setting priorities, timelines, and deliverables for multiple concurrent LED phototherapy product programs (masks, panels, and related devices).
•Client Technical Liaison: Act as the primary technical point of contact for overseas clients, translating client requirements (specs, tolerances, regulatory targets) into clear internal engineering briefs, and communicating design trade-offs, delays, or quality issues professionally and proactively (e.g. phased delivery plans during spec deviations).
•Engineering Oversight: Review and approve PCB schematics/BOMs, LED wavelength and optical power design, thermal and ESD considerations, and mechanical/silicone tooling designs for manufacturability and medical-grade reliability.
•Quality & Testing: Own resolution of technical quality issues (e.g. LED wavelength tolerance deviations, optical power/irradiance testing methodology), and help drive automation of optical testing workflows (e.g. NFC-integrated, multi-channel spectral testing).
•Supplier & Cost Management: Coordinate with key component suppliers (e.g. LED chip suppliers) on inventory, lead times, and cost/quality trade-offs; support commercial quoting and cost analysis for new programs.
•Regulatory & Compliance: Ensure development processes align with ISO 13485, FDA, MDR, and NMPA requirements as applicable to target export markets.
•Cross-functional Coordination: Work closely with production, sales, and R&D teams in Shenzhen to ensure smooth handoff from design to manufacturing.
职位要求
Requirements
•Bachelor's degree or higher in Electrical Engineering, Optics/Photonics, Biomedical Engineering, Mechanical Engineering, or related field.
•8+ years of engineering experience, including 3+ years in a team/project management role.
•Prior experience with LED lighting, optics, photobiomodulation (PBM), or medical device product development strongly preferred.
•Experience managing hardware development programs end-to-end: schematic/PCB review, optical/electrical testing, mechanical tooling, and DFM.
•Familiarity with medical device regulatory frameworks (ISO 13485, FDA, MDR, NMPA) is a strong plus.
•Mandarin Chinese proficiency preferred; excellent English communication skills required (native or fluent). Candidates who speak English only are still welcome to apply.
•Willingness to relocate to Shenzhen, China, and work on-site with the manufacturing team.
•Strong cross-cultural communication skills — comfortable bridging Western client expectations with Chinese manufacturing operations.
Additional benefits:
•Direct exposure to end-to-end product development for a fast-growing export-focused medical device manufacturer.
•Opportunity to shape engineering and QA processes for a company scaling its international ODM/OEM business.