*Hi, * *Please go through the below Requirements and Respond to me ASAP with Matched Profiles and Contact details to my mail id: [email protected]*
There is no client interview here, easily closable. for System Engineer *Need profiles immediately, very quick closure position.* *Please find below 2 mechanical reqs and share profiles ASAP, Kindly feel free to call in case of any queries.* * * *Position 1:* *Duration* :* 6 Months* *Location : Lake Forest, Illinois* *No. of positions: 1* *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 *Position 2:* *Duration : 6 months* *Location : Lake Forest, IL* *No. of positions: 1 * * * *Risk assessment Engineer - 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 -- You received this message because you are subscribed to the Google Groups "oraapps" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/oraapps?hl=en. For more options, visit https://groups.google.com/groups/opt_out.
