This is a key technical leadership role responsible for developing and executing comprehensive testing strategies for client’s software products. You will design, develop, and execute software verification tests for medical devices, and analyze software requirements and design specifications for testability. Collaborating closely with cross-functional teams, including system design, software development, and system verification, you will ensure our medical devices meet rigorous regulatory standards. This role requires a deep understanding of medical device system software, strong leadership abilities, and a passion for ensuring product quality and compliance with regulatory requirements.

Company Profile

Client is a small to mid-sized interventional and diagnostic technology company.

Primary Responsibilities

• Lead the design, development, and execution of both manual and automated software tests to identify defects and ensure product quality.
• Develop and implement software test process documentation including verification plans, designs, protocols and test scripts for comprehensive test coverage.
• Collaborate with software development, product management, and other cross-functional teams to understand requirements and ensure thorough testing.
• Perform risk analysis and develop mitigation strategies to address potential issues.
• Ensure compliance with industry standards and best practices for software testing.
• Mentor and guide junior test engineers, promoting best practices in software testing and quality assurance.
• Continuously improve testing processes, methodologies, and tools to enhance efficiency and effectiveness.
• Provide detailed documentation and reports on test results, defects, and overall software performance.
• Participate in design reviews, code reviews, and other design activities.
• Documents defects capturing steps to reproduce and information for debugging.
• Develops test automation plans including requirements, architecture, and technologies.
• Oversees validation of software test tools.
• Identifies metrics to assess test progress and software quality.

Minimum Qualifications:

• Bachelor’s degree in computer science, Computer engineering or Software engineering. A degree in another engineering discipline is acceptable with demonstrated software experience
• 8+ years of experience in software design verification
• Hands-on experience in manual testing, including understanding product requirements, risk assessment, protocol creation, execution, and reporting
• Experience with Jira, JAMA & product lifecycle management tools
• Proficiency in Python scripting language or other scripting languages
• Strong working experience in Linux and Win OS
• Strong understanding of medical device software standards and regulations (e.g. IEC 62304)
• Proven background in automated test system development
• Experience with automated test equipment validation activities
• Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment.
• Strong analytical and problem-solving skills with the ability to troubleshoot complex system issues.
• Ability to grow productive, trusting, and open relationships with functional partners
• High degree of organizational skills and high attention to detail
• Ability to handle multiple tasks and prioritize effectively
• Ability to work both independently and as part of a team
• Strong initiative, high energy, and passion about new technologies

Preferred Qualifications:

• Graduate degree in computer science, Computer engineering or Software engineering. A graduate degree in another engineering discipline is acceptable with demonstrated software experience
• 10+ years of software design verification experience
• Knowledge of cybersecurity testing
• Experience in system hardware testing
• Supervision and project management experience is desirable
• In-depth knowledge of medical device regulations and standards
• Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical, and human factors
• Knowledge of latest industry trends, emerging technologies, and regulatory changes to continuously improve testing methodologies

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