Biomedical Device R&D Engineer

Advanced Semiconductor Integrations Limited Hong Kong SAR On-site Full Time Entry level Job Highlights Design class-3 implantable neuro-stimulation devices in new start-up at HK science park. Exciting opportunity to involve in innovative medical device design and development Job Responsibilities The Biomedical Device R&D Engineer will use engineering knowledge to design, develop, verify and validate product designs in support of company’s neuro-stimulation devices. Contribute as part of a cross‐functional team in product design and development, process development and optimization, and verification & validation testing to support product transfer to manufacturing. Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.) Prepare technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports to support design control activities. Perform Verification and Validation (V&V) and may draft protocols/reports for approval. Work with engineers & QA to create new components, assemblies, or tools. Conducts testing to verify that the design meets the engineering specifications. Document engineering work in compliance with the company's quality system. Identifies hazards and mitigates risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis. Compiles and analyzes data, identifies causes, draws conclusions, generates reports. Job Requirements Engineering degree desired or equivalent experience in related job field Preferred 2+ yrs Biomedical product or medical device development experience Ability to work independently and good problem-solving skills A team player with great inter-personal skills and strong sense of ownership Good command of English and Chinese Fresh graduates are welcome. Candidate with more experience will be considered as senior engineer Company Overview We are an innovative and energetic startup in the medical device industry, driven by a passion for transforming healthcare through cutting-edge technology. Our team consists of highly experienced professionals with a proven track record in medical device development, ensuring the highest standards of innovation and quality. If you are looking to join a forward-thinking company where creativity and expertise come together to make a real impact, this is the place for you We invite you to be a part of the design team. Job Types: Full-time, Permanent Additional leave Maternity leave Opportunities for promotion Parental leave Schedule: Monday to Friday Supplemental Pay: Performance bonus Yearly bonus Education: Bachelor's Degree (Preferred) Additional Information Job Level Entry level Publish Date 17/06/2025 Job Ref. No. N/A Engineering / Technical Services (Electrical / Electronic / Mechanical / Other) Job Function Medical Science / Technology Company Overview ASI is an Analog, Mixed-Signal & Sensor fabless semiconductor company, and has locations in Hong Kong, the US silicon valley and Asia. Our design team have 25+ years of design experience in Low-Voltage and Low-Power Analog IC, Mixed-Mode IC, Sensor IC and ASIC. Our products include: High-speed high-resolutions ADC, DAC, Digital Isolators, Battery Management System BMS IC, Analog signal chain IC, Power Management PMIC, Sensors, Operational Amplifier, Medical Implantable IC, Wearable and Health Monitor IC, IoT IC. Our technologies have been successfully used in an estimated 1 billion chips/devices. Our customers include US, Japan, China, Europe and Asia companies spanning consumer, medical and industrial applications. Company Overview ASI is an Analog, Mixed-Signal & Sensor fabless semiconductor company, and has locations in Hong Kong, the US silicon valley and Asia. Our design team have 25+ years of design experience in Low-Voltage and Low-Power Analog IC, Mixed-Mode IC, Sensor IC and ASIC. Our products include: High-speed high-resolutions ADC, DAC, Digital Isolators, Battery Management System BMS IC, Analog signal chain IC, Power Management PMIC, Sensors, Operational Amplifier, Medical Implantable IC, Wearable and Health Monitor IC, IoT IC. Our technologies have been successfully used in an estimated 1 billion chips/devices. Our customers include US, Japan, China, Europe and Asia companies spanning consumer, medical and industrial applications. #J-18808-Ljbffr