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该岗位负责医疗器械(自注射装置)产品设计开发与维护工作,执行符合流程的设计开发任务,为生产团队提供技术支持,参与不合格品及投诉调查,主持设计相关根因分析,并维护设计历史文档及提出可制造性改进建议。
About SHL Medical
SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.
Job Overview
Manage, coordinate and perform product design engineering related activities in product development process for medical devices, and ensure the product performance fulfils the defined functional and safety requirement in a product life cycle.
Execute the maintenance, support, and enhancement of product designs after development, ensuring functionality, quality, and continuous enhancement to meet customer needs while maintaining high performance and reliability.
Collaborate closely with cross-functional project teams to ensure that designs meet user needs, quality requirements, and manufacturability.
Main Responsibilities
Support prospecting customer inquiries (pre-development)
Support intakes for customer projects
Execute design and development tasks in compliance with product development process
Execute the tasks of the maintenance, support, and enhancement for the Design production support, including:
provide technical assistance and guidance to production team
participate in NCMR & complaint investigations
lead local RCA investigations for design-related causes
maintain product design & risk management documents (DHF) up to date
propose and assess design improvements for manufacturability, cost, and/or performance improvements
Qualifications
Bachelor degree or above in mechanical engineering or medical engineering;
Independent, multi-learning, and self-motivated.
System-thinking, detail-oriented, and creative.
Be progressive and an opinion-maker.
Great passion in design and methodology.
Above 2 years of experience in mechanical design
Proficient SolidWorks 2D/3D build;
Good English reading, written, presentation skills are essential;
Good cross-functional communication skills;
Good problem-solving skills;
Good planning (Time management and task prioritization) and reporting skills.
Skill of understanding and systematic translation of requirements into product design
Basic knowledge of DFMA (Design for Manufacture and Assembly) and manufacturing process, including injection molding and spring coiling
Basic technical analysis (GD&
T, Tolerance analysis, Statistical analysis)
Basic risk management knowledge (DFMEA)
Good independent and critical thinking
Good cross-functional and cross-site teamwork