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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