Senior Software V&V Engineer, Imaging Systems

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Lead the development and implementation of the Design Verification and Validation (V&V) plan in accordance with regulatory and quality system standards (21 CFR Part 820, ISO 13485, ISO 14971).

• Establish testing strategies, protocols, and acceptance criteria for mechanical, electrical, optical, and overall system performance.

• Construct intricate data sets intended for testing purposes.

• Conduct Statistical Analysis and Exploratory Data Analysis (including descriptive statistics, regression, and visualization).

• Design test methodologies and verification protocols for software products.

• Develop and sustain test master plans, timelines, and resource distributions for various device programs.

• Engage in software development sprint cycles by providing support to the software development team through participation in SCRUMs, design reviews, code reviews, and offering feedback on software verification and validation outputs.

• Work collaboratively with cross-functional teams to comprehend requirements and convert them into detailed test plans and protocols.

• Oversee Data Governance, Access Controls, and the management of PHI Data.

⛳️ Requirements

• A minimum of 5 years of relevant experience in the medical imaging sector (Product Development, Quality).

• Bachelor’s or Master’s degree in Computer Science, Information Technology, or a related discipline.

• Familiarity with non-product software development.

• Proficient programming abilities in Python, particularly in the realms of data science, statistical analysis, big data, and machine learning.

• Experience in quality engineering within quality system regulations, encompassing but not limited to 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP, and/or MDD/MDR.

• Proficiency in issue tracking and project management software such as JIRA.

• Strong grasp of the software development life cycle and testing life cycle.

• Exceptional problem-solving, analytical, and critical thinking capabilities.

• Ability to work effectively in a remote-first team environment and communicate proficiently with Product Managers, Engineers, and other stakeholders.

🏝️ Benefits

• Target annual bonus of 15%.

• Stock options available.

• Paid benefits offered.