ABAXIS
Point of Care Blood Laboratory Systems, Anytime, Anywhere.
Abaxis is a pioneer in the development and commercialization of leading-edge innovative technology, tools and services that support best medical practices, enabling practitioners to respond to the health needs of their patients, while operating economical and profitable practices, at the point of care.
Abaxis Inc, a manufacturer of blood point-of-care diagnostic systems based out of Union City, is seeking qualified candidates for the following role:
DESCRIPTION:
- Help create and review requirements specifications to ensure they are relevant, correct, unambiguous and verifiable.
- Participate in risk assessment/management activities related to software development.
- Create protocols and test plans for new, existing, and updated software to provide objective evidence that the software performs to documented requirements and established standards under both normal and abnormal conditions.
- Perform V&V tasks on Medical Device Software, Quality System Software, OEM Device Software and Software used with or installed in Production Equipment.
- Develop, implement, execute and maintain manual/automated test procedures and documentation. Execute protocols and reports to document software V&V testing.
- Create and maintain “gold” standard data sets for V&V testing.
- Establish traceability from V&V to risk mitigation and specification.
- Monitor software after release for possible issues and requests for changes.
- Conduct testing of third party software or hardware peripherals to ensure compatibility.
- Contribute to the creation and maintenance of V&V SOP’s, DOP’s and Plans.
- High attention to detail.
- Familiar with software documentation for FDA regulated medical device industries.
- Familiar with C, C++, C#, VB, VBA and .net.
- Familiar with Software Version Control and Issue Tracking concepts.
- Excellent skills in the use of Microsoft Word, Visio and Excel.
- Ability to propose creative solutions which meet the organizations objectives while balancing business and compliance issues
- Strong oral and written communication skills.
- Demonstrated organizational, prioritization, and time management skills.
- Ability to multi-task and work independently.
- Ability to work diverse groups and coordinate activities.
REQUIREMENTS:
- Minimum of a Bachelor’s degree in Electrical Engineering, Computer Engineering, Computer Science or Physical Science.
- 3+ years in Medical Device Software V&V Testing
- Documented experience throughout the complete Software Life Cycle.
- Demonstrated experience with electronic test equipment such as oscilloscopes, logic analyzers and DVMs.
- Knowledge of IEC 62304, and GAMP.
- Familiar with EN ISO 14971, IEC 61010, 21 CFR 820, 21 CFR 11.
- Working within a regulated environment with IVD, FDA and CE experience a plus.
Please apply on-line at: www.abaxis.com
ABAXIS IS AN EQUAL OPPORTUNITY EMPLOYER
