Embedded System Software Testing
  • Mounds View, Minnesota, US
  • +914043515100
639 Days ago
Job Description

Hope you are doing well

Please find the below job opportunity and let me know if you have any suitable consultant for it.
No OPT’s & H1B’S please
Can Work on C2C with US Citizen, GC & H4 EAD

Job Role :  Embedded System Software Testing

Location : Mounds View, Minnesota

Duration : 6+ Months

Key skills required for the job are 

Minimum work experience: 7 - 9 YEARS

• Prior medical device manufacturing background and experience required, coordinates with functional manager / SME to create CO and follow through same for closure .
• Ability to review Design Validation /Specifications /documents /Drawings / Details Data collection in EU MDD / MDR Tech files
• Hazard Analysis / Component Design FMEA / review /verification / Updates
• Experience in Specification development, Agile, Documentum or any document management system
• Experience in Process FMEA/ Risk management CAPA and RCA and provide inputs to Design team.
• Validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills.
• Proven ability of working in a cross-functional team environment. Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, QA, etc. as necessary.
• Communicate significant issues or developments identified during production, validation and qualification activities.
• Knowledge on ISO 13485/Part 820 / ISO 14971 and prior Medtronic experience will be preferred. 
Must have Skills:
a) Specification Development
b) Test Method Development and Validation
c) Design Verification and Validation
e) Design Input / Design Output Matrix
f) Change Management Process 
Nice to Have Skills:
a) Experience with or Exposure to implantable / Tissue or Mechanical Heart Valves

Thanks and Regards,

Aziz Ahmed
NuTek Systems
Email : Aziz.ahmed@nutek.systems
Direct : +1 (386) 217-7741

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Required Skills
  • agile,esign Validation /Specifications /documents /Drawings / Details Data collection in EU MDD / MDR Tech files,medical device manufacturing,FMEA/ Risk management CAPA,Mechanical Heart Valves

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Working Hours / Week