Job ID : 29516
Location : Memphis, TX
Company Name : Wipro Limited
Job Type : Full-Time, Parttime, Contract, Training
Industry : Information Technology
Salary : $120,000 - $130,000 per year
No. of Positions : I Have Ongoing Need To Fill This Role
Required Skills : Manufacturing Engineering, Maintenance, Mechanical Engineering
Benefits : Medical Insurance,Dental Insurance,Vision Insurance,401K,Life Insurance
Nice to have:
· Create and execute verification and validation plans, protocols and reports.
· Create or update the risk management file for the product.
· Maintain compliance to the standards and policies of the Laborie Management System, including organizational adherence to the ISO 13485 and ISO 9001 registration standards.
· NOTE: Other duties may be assigned.
· Working knowledge of medical device design control processes, design change and document change control, product lifecycles, and product verification and validation methodologies
· Experience writing test protocols, performing tests, and writing reports specifically in Verification and Validation
· Solid project management experience to drive completion of projects and practical application of a design controlled product development process.
· Experience designing and developing devices with 3D CAD; exposure to 3D printing is a plus
· Experience designing, fabrication and/or specifying of test fixtures, tooling and equipment necessary for development of disposable medical products and processes
· Demonstrated understanding or ability to understand Medical Device QMS and regulatory requirements including FDA CFR 21 820 and ISO 13485, and other applicable standards
· Demonstrated knowledge of CAPA process and root cause investigation
· Demonstrated knowledge of risk management techniques
· Ability to work independently on assigned projects
· Excellent oral communication & report, business correspondence & procedure-writing skills
· PC literacy, ability to work with basic software and spreadsheets; experienced Project tracking software (ie MicroSoft Project, SmartTrack, etc).
· Ability to be hands on and can function independently
· BS Degree in Mechanical Engineering or Biomedical Engineering Areas
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