USA

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.
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