Position Summary:
BioSig Technologies is looking to hire an experienced Senior Software Test Engineer to join our Electrophysiology medical device software R&D team.
The Senior Software Test Engineer creates, modifies, and executes software test plans, automated scripts, and programs for testing complex medical device software in accordance with project requirements, UX design, and medical device industry standards.
An individual in this role will also review designs and participate in meaningful collaboration sessions on how to solve customer problems and participate in determining scope of testing for new projects.
In addition, the Senior Software Test Engineer will lead testing team and direct the work of other team members.
Key Responsibilities:
Perform manual functional testing of new products/product features as well as automated regression testing of existing functionality.
Write, maintain, update, and execute automated test libraries and automated test cases.
Maintain an automated test infrastructure.
Write, maintain, update, and execute manual test cases based on software requirements and specifications.
Write, review, and update product test plans, automated test scripts, and test scenarios.
Perform all tiers of testing, including manual, automated, front-end, and back-end.
Execute test plans, automated test scripts and test cases to ensure that software meets or exceeds specified standards, development specifications, and/or client requirements.
Report bugs and track status through a resolution system.
Build and maintain test tools and test applications to perform automated functional and regression testing as well as model-based architecture testing.
Work closely with development, product development, and operations departments to ensure quality and timely services are delivered to clients.
Maintain a strong working knowledge of the market host systems.
Review system requirements and business processes.
Maintain testing tools to be used by the broader team.
Perform hardware integration testing between data acquisition and data processing.
Competencies Required:
Excellent collaboration and facilitation skills required.
Strong situational awareness, coupled with facilitation, team building, and problem solving.
Able to work as part of an interdisciplinary team but be self-motivated and be able to self-prioritize critical tasks.
Demonstrate basic understanding of IEC/ISO and FDA compliance standards pertaining to critical care medical devices, basic safety, EMC, patient monitoring sensors, alarms, and biocompatibility.
Required education and experience:
Bachelor of Science degree in Biomedical Engineering / Computer Science or equivalent.
Preferred degree in UX design or similar fields such as HCI, Interaction Design, Visual Design, or related degree, (or equivalent combination of relevant education and work experience).
Experience: 10+ years’ experience with a minimum of 5 years of Medical Device experience in Signal Processing domain and a minimum of 3 years of Quality experience or design control experience, Including experience in design control and risk management activities.
In-depth understanding of medical device design control and risk management.
Working knowledge of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
Experience of different testing strategies and methodologies.
Preferred education and experience:
Experience with JIRA/JAMA software tools and their implementation is a plus.
Certification as an internal lead auditor for QSRs and/or ISO 13485 is a plus.
Thorough understanding of FDA Quality System regulations in relation to computer system validation is a plus Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensure compliance of these elements to procedural requirements.
Job Type: Full-time
Pay: $83,000.00
– $142,000.00 per year
Benefits:
401(k)
Dental insurance
Flexible spending account
Health insurance
Paid time off
Vision insurance
Schedule:
Monday to Friday
Work Location: One location