Nityo Infotech Corporation
Pittsburgh, PA
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Job Description :
Role : Mechanical Engineer
Location : Irvine, CA
Full Time (Permanent)
Mechanical Engineering Degree - MUST
8 - 10 years of Medical Device industry experience - MUST
Experience in Product Design and Manufacturing - excellent Manufacturing experience-Must

Below are the Must have Knowledge and Experience related to the medical device industry:
o DOE.
o Process Development.
o Develop manufacturing tool/fixture/test equipment.
o Equipment IQ (Write, Execute, and Complete
o Knowledgeable of Component and Process Qualification and Validation (Write, Execute and Complete
o Knowledge/Experience create test protocol, execute, and complete protocol with summary report, related to component, design and process changes.
o Create and Execute FMEA/PFMEA.
o Have first-hand knowledge/experience in create process flow map, develop project plan using MS Project Gantt’s, Organize and Manage individual project plan/schedule.
o Proficient using CAD and Solid model software to create 2D/3D mechanical component drawing/model and Sub/Final Assembly drawing.
o Proficient read and create mechanical drawing.
o Must have strong written and verbal communication skill.
o Must take ownership and accountability to manage and drive own individual project.
o Good technical analytical skill and logical thinking.
Good to have:
MS Word, Excel.
Knowledgeable of New Product Development process.
Understanding of FDA and Compliance regulations.
             

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