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Biomedical Engineering Specialist
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As a member of our innovative team at Advanced Semiconductor Integrations Limited, you will play a crucial role in shaping the future of medical devices. We are committed to developing cutting-edge products that transform lives.
Key Responsibilities:
- Apply engineering knowledge to design, develop, and validate product designs for our neuro-stimulation devices.
- Collaborate with cross-functional teams to ensure successful product design and development, process optimization, and verification & validation testing.
Responsibilities and Deliverables:
The Medical Device Development Professional will be responsible for:
- Developing and maintaining high-quality documentation to support quality system for design functions.
- Preparing technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports.
- Leading Verification and Validation (V&V) activities and drafting protocols/reports for approval.
- Working closely with engineers & QA to create new components, assemblies, or tools.
- Conducting testing to verify that the design meets the engineering specifications.
- Maintaining accurate records of engineering work in compliance with our quality system.
- Identifying hazards and mitigating risks associated with identified hazards in Design and Process FMEA.
- Compiling and analyzing data, identifying causes, drawing conclusions, and generating reports.
