Eddy Lin Email & Phone Number

New Taipei City, New Taipei City, Taiwan

- Take charge product V&V planning in accordance with IEC/ISO/ASTM standards.- Participated in manufacturing process evaluation (e.g. packaging validation)- Assisted new supplier evaluation and re-validation of outsourcing process (e.g. sterilization process, design change)- Participated in supporting technical documents and deficiency response for TFDA and FDA certification approval.- Introduced the test process into production line for maintenance, inspection, servicing and repair process.- Responsible for technical solution/report per customer complaints and internal requirements (e.g. QSD application)

New Taipei City, New Taipei City, Taiwan

- Obtained IEC certification for surgical navigation robot/navigation software.- Worked on debug and design change evaluation with RD staffs and third-party for design freeze.- Take charge risk assessment review per IEC/ISO standards.- Established a calibration process for measurement equipment in production line.- Take charge technical documents (risk , test plan and summary report) writing/reviewing.

台灣 桃園市 蘆竹區

- Take charge verifying the product, developing test method and implementing design transferin compliance with ISO standards.- Support engineering and RD department for trial testing, specification definition anddesign change evaluation.- Maintained issued test instructions and update test jigs and process for early standardinspections. - Based on customer requirements to develop cost-effective test procedures (Container Free & Plastic Syringe) to meet customer expectations.- Responsible for technical writing and reviewing. (WIs, V&V plans and reports)