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Software Quality Engineer

Apply Now Job ID R-354958 Date posted 12/10/2019

Locations

Louisville, Colorado

Job Description Summary

Job Description

Provide quality software engineering support in design and development of medical device 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 EU MDR, ISO and FDA/QSR Regulations, supporting external audits.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.

•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

QUALIFICATIONS

To perform this job successful, an individual must be able to perform each essential duty satisfactorily.  The requirements listed in this section and below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Ability to perform engineering work of a broad nature with little direction from Quality Management.  Generally, receives guidance on novel or controversial problems.
  • Knowledge of medical device regulation, industry or international standard, including management responsibility. 
  • Ability to interface with regulatory bodies to present technical information.
  • Knowledge of quality systems and relationship to business.
  • Has experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.
  • Ability to participate and provide leadership on teams and maintain positive work environment with those teams. 
  • Excellent communication skills (verbal, written, and presentation).  Understands how to present information dependent upon the level of the audience.
  • 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.

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

EDUCATION and/or EXPERIENCE

•Bachelor of Science Degree preferred or equivalent experience

•3 – 5 years of experience testing software (medical device preferred but not required) as well as establishing and upholding software life cycle processes

LANGUAGE SKILLS

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 from groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS

  • Versed in statistics, modeling, optimization, data presentation and analysis and application to technical problems.

PHYSICAL DEMANDS

May occasionally lift objects up to 25 lbs. 

WORK ENVIRONMENT

This position works in a normal office environment.  The noise level in the work environment is quiet to moderate. 

Primary Work Location

USA CO - Louisville

Additional Locations

Work Shift

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All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com