Engineer

  • RevereIT,
  • Sterling, Virginia
  • 1 month ago
Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
Full Time
$60,000+
Work from home not available Travel required to 100%.

Job Description

RevereIT LLC

45640 Willow Pond Plaza # 200, Sterling, VA 20164

 RevereIT LLC has openings for multiple Entry Level Engineering Positions.

The Job Duties include but are not limited to the following:

Validation Engineer

  1. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.

 

  1. Study product characteristics or customer requirements to determine validation objectives and standards.

 

  1. Perform impact and component assessments for the systems.

 

  1. Develop system specific Commissioning protocols and acquire protocol approvals – pre-functional test plans and functional test plans.

 

  1. Prepare and Revise Standard Operation Procedures (SOPs) for equipment assembly, operation, disassembly, cleaning and acquire SOP approvals.

 

  1. Conduct Factory & Site Acceptance Tests for various Process Equipments.

 

  1. Design validation study features, such as sampling, testing, or analytical methodologies.

 

  1. Execute & Maintain Good Manufacturing Practices (GMP) Documentation for recording Test Results and other execution documentation per Policies and Procedures.

 

  1. Review Turn over Packages, review ETOPs to Complete, Generate and Assist in the resolution of the Exceptions List.

 

  1. Prepare and revise final report for applicable equipment / systems and acquire approvals.

 

  1. Verify all pertinent draft and/or approved documents are accurate and are in as-built condition.
  2. Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
  3. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products such as Installation, Operation, Performance Qualifications.
  4. Maintain databases for validation activities, test results, or validated systems and procedures.
  5. Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.

Minimum Bachelor’s Engineering Degree  in Mechanical,/Chemical/ Electrical/ Biomedical / Biotechnology/ Electronics /Manufacturing/ Industrial / Engineering Technology Management/Engineering Management  or related.

Relocation to Client Sites with short notice is a MUST. Likely candidates will be tested on their general ability to perform the above tasks. E-Mail resumes to hr@revereit.com.

Quality Engineer  (Design Engineering)

  1. Conduct formal technical design reviews throughout the phases of the product development process.

 

  1. Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs.

 

  1. Apply statistical methods and design excellence tools to design verification and validation activities.

 

  1. Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting.

 

  1. Enhance the design control and risk management processes to better reflect state of the practices and drive continuous improvement.

 

  1. Provide service in  areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Product Complaints, Post Market Surveillance, Nonconforming Materials, Risk Management, and Audit Support Functions.

 

  1. Provide technical help and information on medical device regulations to other Cross Functional Teams.

 

  1. Investigate and Trouble Shoot and follow all laws and policies that apply and maintain the highest levels of professionalism, ethics and compliance at all times.

 

  1. Participate in Compliance Program-related activities as required under Standard Operating Procedures.

 

  1. Design biomedical equipment and class I,II &III medical devices.

 

  1. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products such as Installation, Operation, Performance Qualifications.
  2. Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.

 

  1. Coordinate the implementation of Device Testing with affected departments and personnel.

 

  1. Initiate, Manage, and Close Non-Conforming Material Reports (NCMR) and Dispose and/or Quarantine Material appropriately.

 

  1. Perform Risk Analysis to update Risk File (pFMECA) to incorporate New Process.

Minimum Bachelor’s Degree  in Mechanical,/Chemical/ Electrical / Electronics/Manufacturing / Industrial  Engineering / Technology Management  / Engineering Management  or related.

Relocation to Client Sites with short notice is a MUST. Likely candidates will be tested on their general ability to perform the above tasks. E-Mail resumes to hr@revereit.com.

Quality Engineer (Medical Device)

  1. Work with the development team for identifying any discrepancies in the drawings of New Product Development for medical devices.

 

  1. Identify any non-conforming issues during the manufacturing of medical devices and report these issues in the Non-Conforming Material Record (NCMR).

 

  1. Implement Requirement Traceability Matrix comparing the drawing and validated inputs from different departments like design, development and process engineers to analyze in any missing information before launching the final development plan for medical devices.

 

  1. Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of medical devices to meet internal and external requirements.

 

  1. Conduct data mining and use statistical tools like ANOVA (Analysis of Variance), Regression Analysis and Gage Repeatability & Reproducibility to the identify scope of any quality issues pertaining to medical devices.

 

  1. Investigate need for Corrective Action Preventive Action for any recurring non-conforming quality problems in building hybrid circuits for medical devices using DMAIC (Define, Measure, Analyze, Improve and Control) tools like Fishbone Diagram (the cause and effect diagram), 5 Whys and SIPOC (Supplier, Inputs, Process, Outputs and Customers).

 

  1. Design and conduct experiments for process optimization and/or improvement for building medical devices.

 

  1. Author validation documents like Operational Qualification Protocols, Operational Qualification Reports, Process Performance Qualification to determine the accuracy and quality of the process and product (medical devices) for bulk manufacturing of medical devices.

 

  1. Author Engineering Test Protocols/ Engineering Test report with the design team in the completion of product verification and validation for new product development.

 

  1. Perform all work to comply with and support company compliance with cGMP guidelines and FDA guidelines.

 

  1. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products such as Installation, Operation, Performance Qualifications.
  2. Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols.

 

  1. Coordinate the implementation of Device Testing with affected departments and personnel.
  2. Create process and design failure mode effect analysis for medical devices. Conduct Health hazard evaluation for risk associated with the products.
  3. Implement upgrades in system and make sure the products comply with the new upgrades

Minimum Bachelor’s Degree  in Mechanical /Chemical/ Electrical/ Biomedical / Electronics/Manufacturing /Industrial Engineering/ Technology Management/Engineering Management  or related.

Relocation to Client Sites with short notice is a MUST. Likely candidates will be tested on their general ability to perform the above tasks. E-Mail resumes to hr@revereit.com.

Embedded Software Engineer (Medical Device)

 

  1. Analyze validation test data to determine whether systems or processes have met the validation criteria and to identify root causes of problems for medical devices under test.
  2. Design, Develop, Modify and Analyze Embedded Software Verification Plans, Protocols and Reports development process.
  3. Execute test protocols, and write reports to describe program evaluation, testing, and correction.
  4. Participate in Software Verification Plans and Protocol Reviews and other related Design Reviews.
  5. Work with product Development Team to evaluate Embedded System Interfaces, Operational Requirements, and Performance Requirements, and Testability Software.
  6. Create, Identify, Validate, and Use Test Tools that facilitate Data Gathering and Test Method Execution.
  7. Design, Build, Validate Test Automation Solutions and work on Defect Management for to find solution.
  8. Verify testing procedures of Embedded Firmware and Hardware used in Electromechanical Medical Devices to ensure rigorous product testing.)

 

  1. Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
  2. Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results.

 

  1. Test for Functional and Nonfunctional, System Level Integration, Mechanical Operation, Environmental Conditions, reliability performance/load, failure modes, and usability of Embedded Systems.

 

  1. Troubleshoot electrical and electronic component/system failures during assembly of Medical Device.

 

  1. Work on computer assigned Engineering design/program related software to complete engineering design validation or verification tasks.

 

  1. Coordinate Manufacturing, documentation and testing activities with other team members and Quality Assurance specialists to ensure all documentation, testing and requirements are in alliance to design and equipment specifications and compliance with operational safety standards.

 

  1. Monitor and Maintain defects using defect tracking systems and retest to ensure they are fixed by the developers.
  2. Identify risks and provide risk-based testing on Embedded Systems, to ensure they are working in accordance to the User needs and Regulatory Compliance.
  3. Conduct testing on Embedded Systems utilizing automation testing tools.

 

  1. Design or develop automated testing tools.

          Minimum Bachelor’s Degree  in Mechanical,/Chemical/ Electrical/ Biomedical / Electronics /Information Technology / Information Systems/ Manufacturing /Industrial Engineering. Technology Management/Engineering Management  or related.

Relocation to Client Sites with short notice is a MUST. Likely candidates will be tested on their general ability to perform the above tasks. E-Mail resumes to hr@revereit.com.

 

Dice Id : 10429725
Position Id : 5841929
Originally Posted : 12 months ago
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