Development Quality Engineer

Designation: Quality Engineer

Location: USA

Qualification: Bachelor’s Degree


Development Quality Engineer needed to perform the following Job duties :

    •  Risk Management procedures development and remediation
      (The Risk Management process is essential for ensuring the quality of the product. Risk management process shall provide the method to evaluate the Product safety and effectiveness, with respect to the clinical condition and intended use, for the patients, users, and/or when applicable, other factors (such as environment or other persons) during the designated lifetime of the device.) As a Development Quality Engineer, developing risk management procedures involves:      

      • Develop Risk Management Procedure for identifying, assessing, controlling, and monitoring risks throughout all phases of the Total Product Life-Cycle. 
      • Create Risk Management Plans and Risk Management Reports. 
      • Define and document the policy for determining criteria for risk acceptability. 
      • Develop criteria for overall residual risk evaluation and corresponding risk benefit analysis. 
      • Review the suitability of the risk management process at planned intervals to ensure continuing effectiveness of the risk management process and document any decisions and actions taken. 
    • Prepares and/or reviews Standard Operating Procedures (SOPs) and Detailed Work Instructions (DWIs) (The International standards specifies a process for a manufacturer to identify hazards associated with medical devices, in vitro diagnostic /(IVD) medical devices, to estimate and evaluate the associated risks, to control these risks and to monitor the effectiveness of the controls) As a Development Quality Engineer, preparing SOPs and DWIs involves:
      • Apply EN ISO 14971 and EU MDR standards in preparing and remediating Product Development and Risk Management Standard Operating Procedures (SOPs) and Detailed Work Instructions (DWIs).
      • Identify gaps in SOPs according to standards in a timely manner.
    •  Performs component level (DFMECA and PFMECA) and System Level Risk Assessment(Risk Assessment is the overall process comprising risk analysis and risk evaluation. Risk assessment activities shall commence early in the design realization of the product per Product Development Procedure, and continue throughout the Total Product Life-Cycle) As a Development Quality Engineer, performing component and system level risk assessment involves:
      • Perform Mechanical Design Failure Mode Effect and Criticality Analysis (MDFMECA) and Process Failure Mode Effect and Criticality Analysis (PFMECA) for Cardiac Rhythm Management (CRM) products
      • Perform System level risk assessment based on the component interactions, product interactions, and environment interactions.
      • Identify failure modes, failure causes, corresponding severity of harm to patient and, probability of occurrence of harm at component, product, and overall system level.
      • Assess risk for patient for each failure of product during cross functional team discussion.
    • Perform Device Hazard Analysis and Software Hazard Analysis
      • Perform Hazard Analysis associated for Cardiac Rhythm Management (CRM) products which includes electrical, mechanical and software components according to ISO 14971 and FDA (Food and Drug Administration).
      • Responsible for breaking down the device to its lowest level of components and analyzing the individual component for all the possible Hazards in case of failure in functionality of the component.
    • Implements IMDRF codes and corresponding mapping of codes for risk files (The Risk Management Files are created on custom made software and database that need customization to standardize the Systems for all Risk Management activities. One such customization of the software required a mapping of all the complaint codes with the individual Hazard, Hazardous Situation and Harm to the patient to comply with international medical device regulatory harmonization and convergence)
      • Assign internationally approved codes for each failure mode and failure cause combination.
      • Create master list of all possible hazards, hazardous situations and harms mapping.
      • Ensure existing codes compliance with Food & Drug Administration (FDA), NCI and International Medical Device Regulatory Forum (IMDRF) standards.
      • Provide suggestions to the FDA, NCI and IMDRF standard coding systems to include new hazards associated with Cardiac Rhythm Management (CRM) products for component and system level failure modes.
    • Statistical Analysis for probability prediction(Probabilities (P1 (probability of a hazardous situation occurring), P2 (probability of the hazardous situation leading to harm), and P) may be estimated quantitatively or qualitatively. Quantitative estimates should use a direct probability value estimated from predicate product experience, clinical evidence, scientific literature, or other quantitative source. Qualitative estimates may be derived from expert opinion and shall use a scale of one (1) to five (5), representing quantitative ranges)
      • Derive predicate product experience probabilities for hazard analysis for each possible severity for a harm.
      • Perform probability prediction using Monte Carlo Simulation.
      • Prepare summary report for each product regarding overall chances of occurring a severity for a product and escalates the results to the higher management.
    • Post Market Surveillance review and associated risk management files update(Per ISO 14971, the Risk Management Files are constantly subjected to feedback from the market post-production and release of the product)
      • Review product performance during field usage and facilitates updates to the Risk Management File
      • Collect marketing data by various reporting tools (Complaints, NCMR and CAPA) and review analysis (Electrical, Mechanical, Software etc.) provided by the product technicians to provide coverage for existing and new hazards, hazardous situation and harms identified
    • Prepares and/or reviews plan for design transfer from the development phase to product launch(Abbott conducts design transfer to ensure that the device design is correctly translated and transferred into production specifications)
      • Prepare plan for transferring new designs as well as modifications or improvements to existing device designs to production specifications.
      • Ensure the product complies with regulatory requirements and industry standards.


Bachelor’s Degree required in  Mechanical Engineering or Industrial Engineering or Engineering Technology or Industrial & Technical Studies. 

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