Mechanical Engineer
Job ID : 29516
Job Title : Mechanical Engineer
Location : Memphis, TX
Comapny Name : Wipro Limited
Job Type : Full-Time, parttime, contract, training
Industry : Information Technology
Salary : $120000 - $130000 per year
Work Authorization : ["OPT","CPT","F1","H4","L1","Have H1 Visa","TN Permit Holder","Green Card Holder","Canadian Citizen","US Citizen"]
No. of Positions : I have ongoing need to fill this role
Posted on : 08-02-2022
Required Skills : manufacturing engineering, maintenance, mechanical engineering
Benefits : Medical Insurance, Dental Insurance, Vision Insurance, 401K, Life Insurance
Job Description :
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
Company Details :
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