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Mdr quality engineer

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MillenniumSoft Inc

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Location:
United States , Louisville

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

35.00 - 39.00 USD / Hour
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Job Description:

Provide quality software engineering and project management support in development of medical device products, specifically, patient temperature management products. Responsible for performing various software quality assurance activities whose main purpose is to facilitate continuous improvement for both products and processes and to support new product/process development activities.

Job Responsibility:

  • Provide quality software engineering and project management support in development of medical device products, specifically, patient temperature management products
  • Perform software quality assurance activities to facilitate continuous improvement for both products and processes and to support new product/process development activities
  • Activities include software life cycle management, design control & documentation, requirements engineering, test case engineering and coverage, configuration management, risk management, usability engineering, design verification and validation, process validation, failure analysis, corrective and preventive action, performing internal and supplier audits to verify compliance with EU MDR, ISO and FDA/QSR Regulations, supporting external audits
  • Develop, implement and maintain standards for software quality processes, systems and procedures to support the software life cycle
  • Ensure that software project and process control documentation are compliant with established procedures
  • Support Research and Development, Manufacturing, Production and IT in Software Quality Assurance
  • Review product requirements for traceability, risk remediation and testability
  • Review verification and validation deliverables for compliance with regulatory requirements
  • Review software test harness / test cases for clarity and requirements coverage
  • Preparation and analysis of periodic Quality Reports
  • Perform internal and support external audits of products and processes
  • Selection, qualification and monitoring of outside suppliers
  • Preparation and review/approval of Engineering Changes and MRB Materials
  • Collect, analyze and take action on performance measurement indices, statistical capability/ reliability analysis
  • Enhance the Quality Management System in such areas as Design Review Process, Compliance to Standards, Change Management, Software BOM enhancements, and Device History File (DHF)
  • Lead specific continuous improvements initiatives which will evolve into a more robust software quality assurance process
  • Track software problem reports and deviation up to closure
  • Support the development, update, validation, and documentation of software utilized in the automated testing of printed circuit boards and finished medical devices
  • Assist in maintaining, troubleshooting, and repairing software elements of automated test systems utilized in manufacturing and service
  • Support IQ/OQ/PQ activities involving software-based manufacturing and service equipment
  • Develop and maintain records for regulatory requirements related to EU MDR including Trace Matrix
  • Coordinate with cross-functional teams to ensure mitigations are owned
  • Estimate scope and project impacts for mitigation tasks.

Requirements:

  • Bachelor of Science Degree or equivalent experience
  • 5 – 7 years of experience testing medical device software as well as establishing and upholding software life cycle processes
  • 3 – 4 years of managing cross-functional teams in a project setting
  • Familiar with Quality System Regulations 21 CFR 820, ISO 13485: 2003, IEC 62304: 2006, ISO 14971: 2007, IEC 60601-1 2nd and 3rd Edition, ANSI/AAMI/IEC 62366: 2007, ANSI/AAMI HE 75, FDA Guidance on General Principles of Software Validation, FDA Guidance on Applying Human Factors and Usability Engineering, FDA Guidance for the Content of Premarket Submissions for Software Contained in a Medical Device, Regulation (EU) 2017/745
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  • Ability to write reports, business correspondence, and procedure manuals
  • Ability to effectively present information and respond to questions
  • Versed in statistics, modeling, optimization, data presentation and analysis
  • Ability to perform engineering work of a broad nature with little direction
  • Knowledge of medical device regulation, industry or international standard
  • Ability to interface with regulatory bodies
  • Knowledge of quality systems and relationship to business
  • Experience in writing process, software, and equipment protocols/validations
  • Ability to participate and provide leadership on teams
  • Excellent communication skills
  • Understands Fundamentals of Engineering Principles
  • Ability to effectively manage time
  • Ability to handle multiple task assignments
  • Ability to translate quality requirements into product specifications
  • Ability to interpret Regulations, Corporate, Division and Department Procedures
  • Ability to manage project expectations related to mitigation tasks and gap assessments
  • May occasionally lift objects up to 25 lbs.

Additional Information:

Job Posted:
January 11, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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