Senior Biomedical Device Design Engineer

6 days ago


Hong Kong Island, Hong Kong SAR China Advanced Semiconductor Integrations Limited Full time

We are Advanced Semiconductor Integrations Limited, a pioneering medical device company driven by innovation and technology. Our mission is to revolutionize healthcare through cutting-edge products.

Job Highlights:

  • Design class-3 implantable neuro-stimulation devices for our new product line.
  • Pursue innovative medical device design and development opportunities.

Job Responsibilities:

The Senior Biomedical Device Design Engineer will leverage engineering expertise to develop, verify, and validate product designs in support of our neuro-stimulation devices. As part of a cross-functional team, contribute to product design and development, process optimization, and verification & validation testing to ensure seamless product transfer to manufacturing.

  • Create documentation to support quality system for design functions (project plans, concept documents, 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 draft protocols/reports for approval.
  • Collaborate with engineers & QA to create new components, assemblies, or tools.
  • Conduct testing to verify that the design meets the engineering specifications.
  • Document engineering work in compliance with our quality system.
  • Identify hazards and mitigate risk associated with identified hazards in Design and Process FMEA.
  • Analyze data, identify causes, draw conclusions, and generate reports.

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