Need Profiles: There is no client interview here, easily closable

[Mohan Kumar || MSR Cosmos]

 *Hi, *

*Greetings for the Day..!!*

*Please go through the below Requirements and Respond to me ASAP with
Matched Profiles and Contact details to my mail id: mo...@msrcosmos.com*



*There is no client interview here, easily closable.***



*Need profiles immediately, very quick closure position.*

* *

*Position 1*: *Lead Systems Engineer***

*Duration *:* 6 Months***

*Location* : *Lake Forest, Illinois*

* *

*Lead Systems Engineer (LSE) Roles and Responsibilities*

·         *Owns content of all Design Input Documents (DID) (Note:
Subsystem specifications are owned by the project subsystem lead)*

·         *Owns tracing at all levels of the requirements flow down*

·         *Owns tracing to cover risk controls in the HA*

·         *Owns tracing of verification coverage of DID*

·         *Owns the generation of the master trace matrix document*

·         *Owns allocation of DID to subsystem level specifications*

·         *Owns the Requirements Management Plan document*

·         *Determines DHF structure*

·         *Obtains DHF document numbers*

·         *Chief content provider for the Design Inputs Review milestone*

·         *Reviews trace matrix and determines when it is complete and
correct*

·         *Determines when owned documents are published*

·         *Attends, and likely leads DRST*

·         *Attends CFRT and any SCR scrubs*

·         *Reviews content of subsystem level specifications*

·         *May delegate any of these activities to Requirements Analyst or
other Systems Engineer as appropriate*

* *



* *

* *

*There is no client interview here, easily closable.***

*Need profiles immediately, very quick closure position.*

* *

* *

*Position   *:  *Risk assessment Engineer***

*Duration *:*  6 months*

*Location  *:  *Lake Forest, IL*

* *

* **Roles and Responsibilities*

·         *Bachelor's degree in any stream. Mechanical Engineering preferred
*

·         *Experience in working in Medical devices and knowledge in
medical quality process *

·         *Should have worked in medical new product development projects &
sustenance projects*

·         *Experience in change control process*

·         * Should have worked in ISO 13485 / 21CFR820 (design control
processes) compliant environment*

·         * Should be able to own Risk Management activities (Risk
Management Plan, Hazard Analysis, User Error Risk analysis & Risk
Management Report) for Consumables (IV Administration sets, syringes, etc.)
per ISO 14971 standard*

·         * Should be able to review and analyze On-Market product
complaint data and identify the risk controls*

·         * Provides written reports and engineering documentation by
following cGMP practice*

·         * Ability to review and analyze engineering reports /
documentation*

·         *Experience in working on disposable medical devices & Infusion
pump accessories will be an added advantage*

·         *Proficiency in DOORS is preferred*

·         *Excellent written and verbal communication is a must*

* *



*Thanks & Regards*

*Mohan ||  IT Recruiter *

*MSR COSMOS LLC*

*T: 309-365-6526 | F: 925-219-0934 *

*M: mo...@msrcosmos.com*

*GTalk: mohankumar025*

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