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 ***: *[email protected] *Yahoo IM:* Pramod_Beyondtekit1 * * <http://www.beyondtekit.com/> <http://www.linkedin.com/in/pramodjohnmark> ** *Note:* We respect your Online Privacy. This is not an unsolicited mail.. This mail cannot be considered Spam as long as we include Contact information and a method to be removed from our mailing list. If you are not interested in receiving our e-mails then please reply with a "remove" to [email protected] <[email protected]>in the subject line and mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. -- You received this message because you are subscribed to the Google Groups "AJAX_Tools" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/ajax_tools?hl=en.
