Senior Software V&V Engineer, Imaging Systems

Cleerly

1d•$153,000 - $179,000•Remote

About The Position

Cleerly is seeking a software verification and validation (V&V) engineer to ensure the quality of cutting-edge products. This role is crucial for supporting regulatory submissions and product releases by planning, executing, and documenting comprehensive V&V activities in accordance with FDA regulations, ISO 13485, IEC standards, and other applicable regulatory and quality system requirements. The engineer will ensure products meet all defined system and subsystem level requirements and are safe, effective, and compliant for their intended clinical use.

Requirements

5+ years equivalent work experience in medical imaging industry (Product Development, Quality)
Bachelor’s or Master's degree in Computer Science, Information Technology, or related field.
Experience with non-product software development
Strong programming skills in Python across data science, statistical analysis, big data and ML stack
Experience with quality engineering under quality system regulations, including but not limited to 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR
Expertise in issue tracking and project management tools like JIRA
Strong understanding of the software development life cycle and testing life cycle.
Excellent problem-solving, analytical, and critical thinking skills
Ability to work collaboratively in a remote-first team environment and to communicate effectively with Product Managers, Engineers, and other stakeholders

Nice To Haves

Prior experience in utilizing AWS Cloud Services or an equivalent enterprise cloud service provider
Experience in Class II or Class III medical devices is preferred
Experience in Cardiovascular imaging system is a major plus

Responsibilities

Develop and lead the Design Verification and Validation (V&V) plan in compliance with regulatory and quality system requirements (21 CFR Part 820, ISO 13485, ISO 14971).
Define test strategies, protocols, and acceptance criteria for mechanical, electrical, optical, and system-level performance.
Build complex data sets to be used in test.
Perform Statistical Analysis and Exploratory Data Analysis (e.g., descriptive statistics, regression, visualization).
Develop test methods and verification protocols for software products.
Create and maintain test master plans, schedules, and resource allocation for multiple device programs.
Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback on software verification and validation deliverables.
Collaborate with cross-functional teams to understand requirements and translate them into comprehensive test plans and protocols.
Ensure Data Governance, Access Controls, and PHI Data Handling.