Innovations technological

 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: mohan@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: mohan@msrcosmos.com

GTalk: mohankumar025