C. R. Bard, Inc.

Software Quality Engineer

2 weeks ago(1/4/2018 10:01 PM)
Industry / Category
Software Quality Engineer
Job ID
2017-10941
Career Level
experienced
Division
Bard Medical Division
Relocation
Yes
US-CO-Louisville

Overview

This position will provide Software Quality Engineering support to C.R. Bard Medical Division based in Louisville, CO.

 

Provide quality software engineering support in design and 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. These 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 ISO and FDA/QSR Regulations, supporting external audits, personnel training and hands-on software testing.

Summary of Position with General Responsibilities

•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

Essential Job Functions

#LI-CW1

Basic Qualifications

Familiar with the following standards and guidance documents:

 

  • Quality System Regulations 21 CFR 820
  • ISO 13485: 2003 Quality Management System
  • IEC 62304: 2006 Medical Device Software Life Cycle
  • ISO 14971: 2007 Medical Device Risk Management
  • IEC 60601-1 2nd and 3rd Edition Medical Equipment / Medical Electronic Equipment Safety
  • ANSI/AAMI/IEC 62366: 2007 Medical Device Application of Usability
  • ANSI/AAMI HE 75 Medical Device Human Factors
  • FDA Guidance on General Principles of Software Validation: Final Guidance for Industry and FDA Staff
  • FDA Guidance on Applying Human Factors and Usability Engineering to Optimize Medical Device Design
  • FDA Guidance for the Content of Premarket Submissions for Software Contained in a Medical Device

Additional Desirable Qualifications Skills and Knowledge

Versed in statistics, modeling, optimization, data presentation and analysis and application to technical problemss

Education and/or Experience

• Bachelor of Science Degree or equivalent experience
• 5 – 7 years experience testing medical device software as well as establishing and upholding software life cycle processes

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