Medical Device Development Professional
4 days ago
Welcome to Advanced Semiconductor Integrations Limited, where innovation meets excellence. Our team is dedicated to pushing the boundaries of medical device development and transforming lives through cutting-edge technology.
Job Objectives:
- Design and develop class-3 implantable neuro-stimulation devices for our new product line.
- Pursue innovative medical device design and development opportunities.
Key Performance Indicators (KPIs):
The Neurostimulation Device Designer will be measured on the following KPIs:
- Successful design and development of neuro-stimulation devices.
- Effective collaboration with cross-functional teams to ensure successful product design and development, process optimization, and verification & validation testing.
Deliverables:
The designer will be responsible for delivering:
- High-quality documentation to support quality system for design functions.
- Technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports.
- Verification and Validation (V&V) activities and protocols/reports for approval.
- New components, assemblies, or tools created in collaboration with engineers & QA.
- Testing results verifying that the design meets the engineering specifications.
- Accurate records of engineering work maintained in compliance with our quality system.
- Hazards identified and risks mitigated in Design and Process FMEA.
- Data compiled and analyzed, with conclusions drawn and reports generated.
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