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.
该职位将侧重于运用现代设计方法设计和开发高质量制氧机，如设计质量、统计分析、公差分析、限额成本设计，以及面向可制造性、可维护性和可持续性的设计。该职位要求熟悉关键医疗器械标准，精通系统架构、集成和设计验证方面的专业知识。
This position will focus on designing and developing high-quality oxygen concentrators, leveraging modern design methodologies such as design quality, statistical analysis, tolerance analysis, design-to-cost, and design for manufacturability, serviceability, and sustainability. This role requires familiarity with key medical device standards and expertise in system architecture, integration, and design verification.
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 以卓越的功能和性能为重，设计和开发制氧机。
61 Design and develop oxygen concentrators, focusing on functional and performance excellence.
61 运用先进的工程方法，包括统计分析、公差分析和设计质量技术，确保产品可靠稳健。
61 Apply advanced engineering methodologies, including statistical analysis, tolerance analysis, and design quality techniques, to ensure product reliability and robustness.
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 与电气工程师、工业设计师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 electrical engineers, industrial designers, and other stakeholders to optimize designs for manufacturability and serviceability.
61 整合成本意识策略，平衡功能与限额成本设计举措。
61 Integrate cost-conscious strategies, balancing functionality with design-to-cost initiatives.
61 与注塑成型供应商密切合作，设计塑料元件，以达到高质量的生产标准。
61 Design plastic components, working closely with injection molding suppliers to achieve high-quality production standards.
61 开发系统架构和监督系统集成工作，确保产品功能的协调一致性。
61 Develop system architecture and oversee system integration efforts to ensure cohesive product functionality.
61 开展设计验证活动，包括仿真和测试，以确认设计并确保符合监管标准和安全标准。
61 Conduct design verification activities, including simulations and tests, to validate designs and ensure adherence to regulatory and safety standards.
61 支持生产团队，确保从原型顺利过渡到批量生产，同时保持质量。
61 Support the production team by ensuring smooth transitioning from prototype to mass manufacturing while maintaining quality.
61 利用客户和服务团队的反馈，改进产品设计，提升用户体验。
61 Utilize feedback from customers and service teams to improve product designs and enhance user experience.
61 将其他制造商的设计见解融入开发流程，以实现持续改进。
61 Incorporate insights from designs by other manufacturers into the development process for continuous improvement.
61 记录设计流程、分析结果及经验教训，以支持知识管理和持续改进。
61 Document design processes, analysis results, and lessons learned for knowledge management and ongoing enhancement.
能力/成功要素
Competencies/Success Factors
61 机械技能
61 Mechanical 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 机械工程或相关专业学士/硕士学位。
61 Bachelor’s or Master’s degree in Mechanical Engineering or a related field.
61 5至8年产品设计与开发经验，尤其在医疗器械或类似行业领域。
61 5-8 years of experience in product design and development, particularly in medical devices or similar industries.
61 精通现代设计方法，包括公差分析、统计分析、限额成本设计及可制造性设计。
61 Proficiency in modern design methodologies, including tolerance analysis, statistical analysis, design-to-cost, and design for manufacturability.
61 具有使用CAD软件（如SolidWorks、CATIA或同等软件）及仿真工具的丰富经验。
61 Strong experience with CAD software (e.g., SolidWorks, CATIA, or equivalent) and simulation tools.
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 擅长设计塑料零件和与注塑成型供应商协作。
61 Expertise in designing plastic parts and collaborating with injection molding suppliers.
61 具备系统架构开发与系统集成方面的能力。
61 Proven ability in system architecture development and system integration.
61 具备设计验证流程方面的经验，包括仿真与测试。
61 Experience in design verification processes, including simulation and testing.
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.