(Job) Verification and Validation Engineer (Medical Device) – Ann Harbor, MI

Hi,

 

This is my direct client opening for a Verification and Validation Engineer (Medical Device) – Ann Harbor, MI. This is a 3 months contract position. The Hourly rate is DOE. Need only local candidates.

 

Project Overview:

• Contractor will review, update, and expand an existing Verification and Validation (V&V) plan for complete testing of the device and for regulatory purposes, such as a 510(k) submission and FDA audit. 
• The plan will include management of vendor V&V.
• The expected workload is 400 hours, much of which may be worked offsite.

 

Qualifications:

• Must have experience with V&V of Class II electronic medical IVD equipment containing embedded firmware.
• Must have experience with managing EMC and safety testing, such as IEC 60601 and  IEC 61010 standards
• Must have performed V&V for a Class II medical device that has earned regulatory approval and has been deployed in the market. Experience with V&V for a Class III device is a plus.
• Must be able to travel to Ann Arbor, Michigan at least one day per week.
• Desired to have V&V experience with Class III closed-loop feedback devices.
• Desired to have familiarity with ISO 15197: 2003, IVD device requirements for blood glucose monitoring.

 

Please complete the following skills-matrix and send back with your updated resume.

Full Name:
Degree Major:
Total IT exp:
Total exp as Verification and Validation Engineer:
Total exp V&V of Class II electronic medical IVD equipment:
Total exp in managing EMC and safety testing, such as IEC 60601 and  IEC 61010 standards:

Total exp with V&V for a Class II medical device that has earned regulatory approval and has been deployed in the market:

Total exp with V&V for a Class III device:

Total exp with V&V experience with Class III closed-loop feedback devices:

Total exp with ISO 15197: 2003, IVD device requirements for blood glucose monitoring:
Hourly rate:

Whether is it C2C/1099/W2? If 1099, specify the corporate name:

Day Phone #:
Evening Phone #:
Cell Phone #:
Availability:
Current City/State:
Work Status (US Citizen / Green Card / Others):

Have you applied recently for this requirement earlier through any one else? Y/N:

Are you ready to relocate on your own expenses (Yes/No)?
Are you ready for Face to Face Interview on your own expenses?

 

Note: If you have experience in all the skills than it should be show in projects as per skill matrix. Because I get feedback from the client, telling me the skill mentioned in the matrix is NOT FOUND in the resume..

 

2 references required. These references should be US citizens and you reported directly or above their immediate management. All the references should have the details like: we will not contact your references before intimate you, but at the time of submission, we required 2 references with email id and contact number.

 

 

Name:

Title:

Email-id

Tel#

Company name:

Visa Status:

 

Name:

Title:

Email-id

Tel#

Company name:

Visa Status:

 

 

 

Thanks & Regards……… 

 

Pramod Dubey

 

BeyondTek IT - "Think Human. Think Technology. Think Beyond."  

Phone (: 714-857-2002 Extn: 801  Fax 7: 714-364-9705

E-mail *: Pramod@beyondtekit.com

Yahoo IM: Pramod_Beyondtekit1

 

     

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