REGULATORY/QUALITY ENGINEER - SOFTWARE PRODUCTS

POSITION DESCRIPTION:   

This is a unique position for a biomedical regulatory/quality professional with strong software engineering background to ensure the quality of medical software products throughout their entire life-cycle, to provide timely information feedback to the software development team, and to participate in software design activities as they pertain to performance, quality and suitability for test. Specifically, Software Quality Engineer is responsible for developing, documenting, implementing, or reviewing software specifications, test plans and reports, software quality assurance standards, support of software configuration control, V&V of software, maintenance of the known software product defect lists and initiate the regulatory submission process to FDA. Additionally in conjunction with R&D define and track and report software quality metrics. Some regulatory affairs experience is required.

RESPONSIBILITIES: 

•  Conducts/participates software validation activities for software medical devices
• Provide key input to software development plans for the required deliverables based on risk.
• Participate in the risk analysis process, and provide key inputs with respect to software risks.
• Participate in the development and review of software system requirements.
• Responsible for conducting early requirements based testing.
• Prepare/track/report software anomaly/bug reports.
• Participate in technical design and phase end reviews.
• Review and participate in software design documentation, software unit level and/or integration testing.
• Responsible for independent manual software system test protocol and report.
• Update changes to documentation as necessary.
• Communicate regular project status and metrics regarding product readiness and software quality.
• Provide authoritative guidance on medical device software regulatory requirements.
• Perform DHF audits to quality system requirement
• Responsible for managing Internal Audit System, Document Control activities, CAPA System and Quality System requirements in this facility
• Initiate the regulatory submission process to FDA by planning and assembling the documentation necessary for successful approvals.
• Capable of performing Internal Audits to ISO: 13485:2003 & 21 CFR 820 requirements.

REQUIREMENTS:

• BS degree in scientific discipline/computer sciences, preferably in the Life Sciences, Biomedical, Mechanical Engineering, or equivalent education and work experience required.
• Minimum of 2 years of quality in medical device industry is desired but will accept similar experience.
• Experience testing software applications
• Demonstrable record of working on project teams and writing and developing software documentation.
• Strong background in software quality life cycle management.
• Some medical device regulatory affairs experience is required.
• Excellent written oral, communication, and Microsoft Office applications skills.
• Knowledge and experience with some or all of the following medical device software standards and industry guidance documentation: QSR/GMP, IEC 60601-1-4, ISO 14971, AAMI TIR 32, AAMI TIR 36, AAMI SW68, FDA General Principles of Software Validation.
• Experience using a software requirements management tool and bug tracking tools a plus

• Proficient in technical writing skills, communications, and with various computer applications.
• Motivated and a self starter

THE COMPANY:

iCAD, Inc. (Nasdaq: iCAD) is an industry-leading medical device provider of Computer-Aided Detection (CAD) solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing cancer earlier. iCAD offers a comprehensive range of high-performance, upgradeable CAD systems for the high, mid and low volume mammography markets. iCAD is entrusted with the task of early cancer detection by over one thousand women's healthcare centers worldwide. For more information, call +1 877 iCADnow or visit www.icadmed.com.

COMPENSATION:

iCAD offers a competitive salary with a comprehensive benefits package including Health, Dental, Short Term Disability, Long Term Disability, 401k, Section 125 Health and dependant care accounts and Company provided Life.

LOCATION: This position is based out of our Beavercreek, OH office.

CONTACT: Please forward cover letter, resume and salary requirements to hr@icadmed.com

 

 

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