Mechanical Design Engineer- Medical Devices
EXPERIENCE & EDUCATION
Bachelor’s Degree in Mechanical Engineering or equivalent with 5 to 8 years of Product Development experience.
KNOWLEDGE, SKILL, AND ABILITY
In-depth experience in CAD tools such as Pro-E Creo/Solid works is expected.
Expertise in Robust Modeling and Detailing practices following the ASME guidelines.
Strong Knowledge and application of GD&T including Tolerance stack-up analysis.
Strong knowledge of metal manufacturing processes. Knowledge on 3D printing and additive manufacturing technologies is an add-on.
Knowledge on Engineering Change management processes and PLM tools such as Agile, PTC Windchill is preferred.
Strong understanding of medical device standards , guidelines and regulations per ISO 13485, ISO 14971 and Design controls ( 21 CFR Part 820).
Ability to create, assess or review applicable product DHF deliverables such as Risk files, Sterilization reports, Bio-compatibility reports etc. along with support from relevant project stakeholders.
Strong knowledge of Engineering fundamentals and application of same during concept generation or re-design of products.
Able to effectively work with cross functional teams in a multinational matrix organization
Superior written and verbal communication skills required.
Good attitude and team player.
Skills & Experience
Creo, GD&T, SolidWorks
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