| Job title | Position type | Release time | Working place | |
|---|---|---|---|---|
| Mechanical Engineer | R&D | 2022.09.01 | USA | more |
| Job description： • Product design and development support from concept to post product launch • Generate solid models, drawings, and bills of materials • Create design specs, protocols, and V&V reports • Develop Design History Files (DHF) and Risk Management Files • Perform basic structural and thermal analysis if needed • Design test fixtures, build prototypes, and conduct lab testing • Support HFUE in product design per FDA requirements • Interface with vendors related to PO and MRB issues • Collaborate with ISC to address manufacturing issues • Work with global team and consultants to overcome technical challenges Qualifications： • BS degree in Mechanical Engineering or related field • 5+ years of professional experience in 3D CAD modeling • 3+ years of professional experience in Class III medical device R&D • Proficient in creating component/assembly drawings and BOM • Experienced in geometric dimensioning & tolerancing • Experienced in design documentation including URS, PRS, DRS, and V&V reports • Familiar with manufacturing process, DFM and DTC • Familiar with medical device regulations and standards: 21 CFR 820; ISO 14971, 13485, 60601; FDA Human Factors Guidance, etc. • Strong interpersonal communication and technical writing skills • Ability to work in a dynamic, multi-lingual environment • Up to 25% travel • Legally authorized to work in the U.S. |
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| Embedded Software Engineer | R&D | 2021.08.30 | USA | more |
| Job description： • Use C/C++ programming languages in RTOS system to develop high quality and maintainable codes for Class III medical devices • Use C# for PC UWP/WPF application • Perform tasks from basic coding to change requests • Design and document modularized software architecture • Analyze product level requirements and generate software requirements specification documents • Contribute to team activities on DFMEA, risk management, etc. • Establish and improve software V&V methods • Prepare software unit test, system integration test, and product acceptance test including plan, cases, execute and report • Participate in software design review, process review, and other interface reviews • Work closely with EE team for PCB design, IC selection and device driver implementation • Provide technical support on customer sites, interacting with customers for future enhancements Qualifications： • BS in Computer Science or related field; Advanced degree preferred • 3+ years of relevant work experience • Expert in C/C++ programming languages for embedded systems; medical device or safety critical applications experience is a plus • Experienced in Windows application programming • Familiar with any 16-bit/32-bit Microcontroller architecture, board bring up and device driver experience. Has hands-on experience with embedded software debugging tools and software • Fluent in software fundamentals including software design, algorithm development, testing performance and data analysis • Has knowledge of common communication protocols used on embedded systems (UART, CAN, SPI, I2C, XPC, UDS) • Experienced in high quality documents preparation, including system requirements, product specification, state diagrams, flow charts, etc. • Knowledge of FDA regulatory requirements (e.g. IEC 62304, ISO14971) is a plus • Ability to work in a dynamic multi-lingual environment • Strong interpersonal, communication and technical writing skills |
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