Sr. R&D Engineer-PM

Date: 2020-06-19

Job Responsibility:

- Project management for new product development

- Design, develop, and refine new products and processes

- Hands-on work to build early concept prototypes

- Develop and validate test methods

- Conduct product verification, validation & qualification testing

- Identify process requirement, develop and improve process parameters

- Identify and improve equipment for product development and testing

- Write and execute test protocols, analyze test data, write test reports

- Perform design and process FMECA

- Create procedure, BOM, router, draft drawings compliant to standards

- Communicate with vendors to determine material requirement, and perform supplier quality management 

- Work closely with other functional groups to identify and coordinate efforts

- Identify problems and recommend solutions

- Interface with clinicians to identify novel solutions to clinical problems

- Gather input from clinical, marketing, literature and other sources

- Manufacturing transfer

Qualification:

-  Minimum bachelor’s in engineering 

- 5-8 years of experience in medical device process and design

- Experience with neurovascular implant processing and design. 

- Project management experience required

- In depth understanding of neurovascular coils. 

- Experience with mechanical detachment systems 

- Self-starter, driven to take initiatives to solve problems 

- Ability to work independently and management time effectively

- Strong analytical and organizational skills

- Proficient in Microsoft Office Suite, Adobe Reader, SolidWorks

- Understanding GMP and ISO 13485 

- Understand FDA/CE regulatory requirements for product testing 

- Proficient email communication with US/European suppliers in English 

- Excellent verbal English, excellent vocabulary in technical neurovascular discussion


Location:

Shanghai

Email to:

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