Customer Requirement Collection and Analysis.
Interface with clinicians to identify unmet clinical needs.
Gather input from clinical, marketing, literature and other sources.
On market product’s benchmark.
Hands-on work to build early concept prototypes.
Advanced material definition and Supplier selection, design phases component quality management.
Product concept creation, selection and refine.
Modeling and Drawing review and release, component specification creation and release.
Product specification definition and maintenance.
Technical feasibility analysis and tests.
Design, develop, and refine new products and processes in R&D lab.
Develop and validate test methods.
Conduct design verification and validation, including animal study and physician validation.
Write and execute test protocols, analyze test data, write test reports.
Perform User and Design FMECA.
Create procedure, BOM, router, draft drawings compliant to standards with Cross functional support.
Identify process requirement, development and improve process parameters with Cross functional support.
Identify problems and recommend solutions, continue design optimization.
New idea collection during projects execution.
Patent draft and application.
Minimum bachelor in engineering or similar，Master is a plus. 985，211 university is a plus.
5 years of experience in medical device process and design.
Design thinking and design of experiments knowledge.
Experience with neurovascular implant processing and design is a plus.
Self-starter, driven to take initiatives to solve problems.
Ability to work independently and management time effectively.
Strong analytical, organizational skills and teamwork.
Proficient in Microsoft Office Suite, Adobe Reader, SolidWorks.
Understanding GMP and ISO 13485, FDA/CE regulatory requirements for product testing.
Presentation skill is a plus.
Proficient email communication with US/European suppliers in English.
Excellent verbal English, excellent vocabulary in technical neurovascular discussion is a plus.
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