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 FMEA.
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.
Minimum bachelor’s in engineering.
5-8 years of experience in medical device process and design.
Experience with neurovascular implant processing and design.
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.