Senior Software Verification Engineer
Description
The Senior Software Verification Engineer is an essential team member for our capital equipment product pipeline, and a key contributor for new product development programs. This represents an excellent opportunity if you are encouraged by building groundbreaking surgical capabilities and working in a multi-functional environment!
The Senior Software Verification Engineer will provide technical leadership and execution for the verification and validation (V&V) strategy for the Advanced Imaging system. The individual should have strong interpersonal skills as they will work closely with systems engineering, design and development engineering, clinical engineering, and quality engineering to develop and ensure the testability of requirements, while developing and validating test methods that will demonstrate the safety and effectiveness of the Advanced Imaging system.
Key responsibilities include:
- Creates and acts on opportunities to automate testing, optimize test processes, lead develop of integration, regression, and stress tests using industry standard tools.
- Provides technical leadership and contributes to system V&V engineering activities via an indirect authority structure.
- Develops and implements software integration test throughout the product lifecycle.
- Leads the planning, development, and execution of system V&V objectives, e.g. test plans, test protocols, test cases, test reports.
- Partners closely with developers and incorporates test planning into design and development phases and is key contributor to the development of system requirements, architecture, and design.
- Supports the team in investigations for identifying the root cause of failures and definition and implementation of control measures.
- Assures good documentation practices are followed in the V&V process.
Qualifications:
- A results and performance driven demeanor with strong sense of accountability is required.
- A Bachelor’s degree in Engineering is required.
- Minimum of 6 years new product development experience.
- Previous experience and proven accomplishments implementing test engineering and
- Verification &Validation (V&V).
- Excellent understanding of requirements management, configuration management, product hardware and software V&V, defect management and risk analysis.
- Experience crafting test strategies based on requirements, architecture, and design.
- Experience in test design development and validation, including statistical techniques.
Preferred Skills:
- Experience with industry standard software development and automation tools in any of the following: (Python, JIRA, Jenkins, Git, Docker, etc).
- Solid understanding of ISO 14971, 21 CFR 820, Design Controls, IEC 60601, IEC 62304 and other relevant medical device standards.
- Proven results in technical leadership, development and mentoring, and directing a team across multiple sites.
- Understanding of surgery, surgical procedures, and the design and application of surgical devices, as well as the quality system and regulatory environment.
- Experience developing complex medical capital equipment, most preferably minimally invasive surgical visualization systems.
- Experience with Continuous Integration/Continuous Delivery (CI/CD).
- Experience with building test automation capabilities from ground up.
- Experience with embedded systems troubleshooting and testing.
- ISTQB Certification.