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Engineering Documentation Analysis AMH Engineer
(Jobs in Boston, MA)
 
Requirement id 69713
Job title Engineer
Job location in Boston, MA
Skills required Risk Management, Engineering, Documentation, Analysis AMH
Open Date 08-May-2018
Close Date
Job type Contract
Duration 12 Months
Compensation DOE
Status requirement ---
Job interview type ---
   Email Recruiter: coolsoft
Job Description Engineer: Risk Management, Engineering, Documentation, Analysis AMH

Start Date : 05/31/2018
End Date : 05/31/2019
Submission Dead Line : 05/14/2018
Description :

Expectations;
Maintain risk management file for product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation.
Perform systematic risk analysis against features, requirements, architecture, interfaces, and designs, through the appropriate application of risk management techniques (e.g. hazard analysis, risk/benefit analysis) to understand product and process robustness.
Assure compliance to organizational procedures, regulatory requirements, and industry standards, and timely completion of assigned CAPA and audit findings.
Partner with development to develop test plans to demonstrate product reliability goals are achieved
Analyze designs to translate identified hazards into probability of user harm
Quantify residual risk, and perform risk/benefit analysis
Actively communicate findings to Quality, Development, and Operations teams.
Understand therapy (clinical) performance, product function(s), and product use environments to appropriately and strategically apply technical knowledge, risk management tools, and methodologies to drive safety improvements

Requirements;
Bachelors Degree (4-year) in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related STEM field
4-5 years of Medical Device Experience
Strong Quality Engineering Experience (ideally Class III Medical Devices)
Proven experience working with Risk Management data and documentation
Knowledge of ISO 14971 standards
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Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 69713 while calling.
 
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(Engineer: Risk Management, Engineering, Documentation, Analysis AMH in Boston, MA)
     
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