直属上级
Reports to
硬件工程经理
Manager, HW Engineering
岗位描述
JOB DESCRIPTION
概要/目标
Summary/Objective
为新产品设计与开发项目提供专业知识。工程师将负责设计和开发活动，以及维护和制造支持类任务。工程师将加入跨职能设计团队，负责在整个生命周期内为项目和产品提供支持。
Provides technical expertise in new product design and development projects. The engineer will be tasked design and development activities as well as sustaining and manufacturing support type tasks. The engineer will be part of a cross functional design team and will be responsible for supporting projects and products throughout the entire life cycle.
该职位的工作重心是为高质量制氧机设计和开发电气系统，具体包括电路板开发、电路图设计、元器件工程设计、低压模拟设计，以及搭载微控制器和嵌入式系统的主板的数字设计。该职位要求熟悉关键医疗器械标准，精通电气工程设计工具，并具备强大的测试能力。
This position will focus on designing and developing electrical systems for high-quality oxygen concentrators, specializing in circuit board development, schematic designs, component engineering, low-voltage analog design, and digital designs for motherboards with microcontrollers and embedded systems. This role requires familiarity with key medical device standards, expertise in electrical engineering design tools, and strong testing capabilities.
基本职责
Essential Functions
对能力稍逊者可以适当调整，要求能完成基本的职责。
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
61 为制氧机设计和开发电气系统，包括印刷电路板（PCB）、电路图及整体系统架构。
61 Design and develop electrical systems for oxygen concentrators, including printed circuit boards (PCBs), schematics, and overall system architecture.
61 运用先进的工程方法，包括统计分析和设计质量技术，确保电气设计稳健可靠。
61 Apply advanced engineering methodologies to ensure robust and reliable electrical designs, including statistical analysis and design quality techniques.
61 确保符合ISO13485、IEC60601、IEC80601以及FDA和其他监管机构要求的其他医疗器械标准。
61 Ensure compliance with ISO13485, IEC60601, IEC80601, and other medical device standards as required by FDA and other regulatory agencies.
61 与机械工程师、固件开发人员和其他利益相关者开展跨职能协作，优化设计，提高可制造性和可维护性。
61 Collaborate cross-functionally with mechanical engineers, firmware developers, and other stakeholders to optimize designs for manufacturability and serviceability.
61 为集微控制器和嵌入式系统于一体的主板开发低压模拟设计和数字系统。
61 Develop low-voltage analog designs and digital systems for motherboards that integrate microcontrollers and embedded systems.
61 进行元器件工程设计，以选用和鉴定电气元件件，确保最优性能和成本效益。
61 Perform component engineering to select and qualify electrical components, ensuring optimal performance and cost-effectiveness.
61 开展设计验证与测试，包括仿真、原型制作及故障排除，以确认设计并满足监管要求和性能要求。
61 Conduct design verification and testing, including simulation, prototyping, and troubleshooting to validate designs and meet regulatory and performance requirements.
61 支持生产团队，确保从原型顺利过渡至批量生产，同时保持质量标准。
61 Support the production team by ensuring a smooth transition from prototype to mass manufacturing while maintaining quality standards.
61 将其他制造商的电气设计见解融入开发流程，以提升产品质量。
61 Incorporate insights from electrical designs by other manufacturers into development processes to enhance product quality.
61 运用电气工程设计工具，绘制详细而精确的电路图、布局图，并进行仿真模拟。
61 Utilize electrical engineering design tools to create detailed and accurate schematics, layouts, and simulations.
61 编写、调试、部署和测试用于控制主板的固件
61 Write, debug, deploy, and test firmware that controls the motherboards
61 设计、选择并测试用于板载连接的低功耗蓝牙（BLE）电路和芯片
61 Design, select, and test Bluetooth Low Energy (BLE) circuits and chips for on-board connectivity
61 记录设计流程、分析结果及测试成果，以实现有效的知识共享与持续改进。
61 Document design processes, analysis results, and testing outcomes for effective knowledge sharing and continuous improvement.
能力/成功要素
Competencies/Success Factors
61 电气工程技能
61 Electrical Engineering Skills
61 项目/任务管理能力
61 Project/ Task Management
61 分析技能
61 Analytical Skills
61 团队协作意识
61 Team Orientation
61 指导/培养他人
61 Coaching/ Developing Others
61 问题解决能力
61 Problem-Solving
61 领导力
61 Leadership
差旅
Travel
偶尔需要出差，包括赴其他地区或国家参加培训与技术协作的国际差旅。
Occasional travel as needed, such as international travel to other sites and locations for training and collaboration purposes.
学历与经验要求
Required Education and Experience
61 电气工程或相关专业学士/硕士学位。
61 Bachelor’s or Master’s degree in Electrical Engineering or a related field.
61 5至8年电气设计与开发经验，尤其在医疗器械或类似行业领域。
61 5-8 years of experience in electrical design and development, particularly in medical devices or similar industries.
61 精通电路板开发、电路图设计和元件工程。
61 Expertise in circuit board development, schematic design, and component engineering.
61 具备为搭载微控制器和嵌入式系统的主板进行低压模拟设计和数字设计的经验。
61 Experience in low-voltage analog design and digital designs for motherboards with microcontrollers and embedded systems.
61 熟悉医疗器械的监管要求和标准，包括ISO13485、IEC60601、IEC80601以及FDA要求。
61 Familiarity with regulatory requirements and standards for medical devices, including ISO13485, IEC60601, IEC80601, and FDA requirements.
61 熟练使用电气工程设计工具（如Altium、OrCAD或类似软件）及仿真工具。
61 Strong proficiency in electrical engineering design tools (e.g., Altium, OrCAD, or similar) and simulation tools.
61 具备设计验证测试能力，包括故障排除和失效分析。
61 Proven ability in design verification and testing, including troubleshooting and failure analysis.
61 能将其他制造商设计中的知识有效融入开发流程。
61 Ability to incorporate knowledge from designs by other manufacturers into development workflows.
61 出色的问题解决能力、细节把控力及多项目管理能力。
61 Exceptional problem-solving skills, attention to detail, and ability to manage multiple projects.
61 出色的沟通与文档编写能力。
61 Excellent communication and documentation skills.