Job Description :
Must have Medical Device Testing experience Software quality test engineer not hardware, or Validation engineer that tested Software. Not Hardware Quality engineer.
Southborourgh MA
Flex work hours
Duration: 3-6 months extendable
Software Test Engineer with Medical Devices Testing Exp.
The Lead Software Test Engineer is a technical position responsible for testing and verification of software solutions developed by Full Spectrum Software and by our clients. This role is responsible for ensuring that tests are sufficiently defined, the testing process is followed, and test plans are executed as defined by Full Spectrum Software’s Quality Management System and client expectations.
Much of our work is in the medical device field. The ideal candidate will be an experienced SQA engineer for FDA-regulated medical device software and/or software solutions involving hardware interfaces. Good understanding of testing methodologies for desktop, embedded, and mobile systems is a must.
This is a full-time position at our facility in Southborough, MA. Some work at our clients’ sites in the greater Boston area may be required.
Responsibilities
Review requirements, specification documents and develop Test Plans.
Estimate, plan, develop, execute, and maintain test cases and test protocols for products under development.
Perform Software, Hardware, Application, GUI and Back-End testing.
Create automated tests as appropriate using established framework.
Ensure that FDA-regulated medical products are tested in adherence to the applicable standards and regulations (ISO 13485, IEC 62304) and best practices.
Work with project management to meet the testing milestones and deliver high quality solutions on time.
Represent the Full Spectrum Software QA team in client interactions.
Share domain knowledge with the rest of the team to continually expand the overall group capabilities.
Required
Qualifications
5+ years of software development testing experience.
3+ years of experience with manual testing of software for hardware control or embedded systems.
Experience testing products in various operating environments, such as:
- Microsoft Windows
- Embedded Linux / Kiosk
- Mobile iOS and/or Android
- Web
Experience with verification of regulated medical device software.
Experience in estimating, prioritizing, planning and coordinating testing activities.
Experience developing and maintaining comprehensive test documentation and requirements-to-tests traceability.
Essential Skills
Strong hands-on test case and test protocol writing skills.
Thorough understanding of smoke testing, black-box, and non-black box testing, as well as regression testing.
Understanding of all phases of the Software Development Life Cycle in a regulated environment.
Excellent troubleshooting skills to help isolate the cause of a defect.
Strong oral and written communication skills.
Ability to balance multiple assignments in a fast-paced environment.
Ability to interact directly with clients.
Must possess a strong sense of ownership, responsibility, and initiative.
Experience using SQL/T-SQL.
Bachelor’s degree in computer science, engineering, science, or related discipline.
Pluses/Nice to have
Experience working with real-time software products and networking products.
Experience with web and client/server technologies, relational databases, network and infrastructure
Experience with creating autonomous testing for both software and hardware-embedded systems.
Experience using TFS, Jira or equivalent.
Experience with Agile Application Development and Scrum methodologies.
Compensation
Competitive salary and benefits including 401k, paid vacation time and health insurance.
Looking forward for your response.