Hi

Hope you are doing well

I am Smith, working as a recruiter with Infotree Service Inc.

I am currently working on “*Reliability/ Risk Engineer*” position with
*Medtronic*

I will appreciate your response at the earliest, as the managers tend to
move fast!

 *NOTE  :* *SEND RESUMES WITH THESE DETAILS , Profiles with all mandatory
details would be processed with TOP Priority*





*Name (First & Last)*



*Contact No.*



*Email ID *



*Current Location*



*Willing to Relocate if need*



*Work Visa Status*, *Expiry Date*



*Availability * How soon can you join?*



*Reason for change*





*Are you fine with drug and background check?*





*Skype ID*





*Last 4 Digit SSN No.*



*DOB(Day, Month)*



*Higher Education, Year of Completion *





*Job Title*

*Reliability/ Risk Engineer*

*Project Location*

*Minneapolis ,MN 55432*

*Duration*

*12+ months /Contract*

 *MOI * *:  * *Telephonic + skype*

*Skills*

To lead risk assessments and support systems engineering for a hemodialysis
system being developed by Renal Care Solutions. through technical planning,
system level evaluation, verification and validation. To provide
engineering expertise on cross-functional development project teams.

*Main Job Duties/Responsibilities*
• Lead risk assessments at the patient hazard level, the detailed design
level, and from a human factors perspective
• Take a system view of safety hazards and understand the concerns of these
hazards from clinicians/customer perspective.
• Translate risk mitigations and safety needs into system/subsystem
requirements and/or product design performance targets.
• Facilitate risk analysis tools such as *DFMEA, HACCP, FTA, and HA* with
small development sub teams
• Work with individual engineers, small engineering groups, and key
management personal to develop and improve risk management deliverables and
processes.
• Author risk – benefit analysis for a new hemodialysis device
• Compare risk rankings of a new hemodialysis device against current
in-market devices and current standard of care
• Apply established SOP's, and develop new processes as needed, to ensure
that newly developed devices are developed with thorough consideration or
risk
• Collaborate with quality and regulatory colleagues to ensure compliance
• Participate in the identification and resolution of complex system issues
through interfacing with engineers representing other components
• Develop technical briefs evaluating technical tradeoffs and proposing a
pathway forward
• Evaluate device use cases to define system requirements and evaluate
technical tradeoffs.
*SPECIALIZED KNOWLEDGE REQUIRED*
• Expert in ISO 14971 2007 and ISO 14971 2012 edition
• Experience authoring FMEA, FTA, HACCP, and other similar risk analysis
tools
• Experience understanding and assessing patient facing/clinical risks
• Strong written and verbal communication
• Attention to detail, thoroughness
• Able to work in direct, cross-functional and cross-cultural teams
• Strong organization and time management skills; ability to manage
multiple priorities
• Self-starter, strong work ethic and initiative in accomplishing
objectives
*JOB QUALIFICATIONS*
• BS BME, ME, Systems, Biology, Physiology or other
• 5+ years of related experience
• Experience with leading risk assessments
*DESIRED/PREFERRED QUALIFICATIONS*
• Experience leading risk assessments for complex medical devices
• Hemodialysis experience
• Strong leadership skills
• Medical Device development experience
• Highly skilled at delivering in an ambiguous environment.
• Entrepreneurial spirit



Thanks & Regards



Smith,

Sr. Technical Recruiter

Infotree Service Inc.

215 Ann Arbor Rd.

Suite 304

Plymouth, MI 48170

734-446-7070

Fax- 734-345-4247

[email protected]

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