Cleerly

Engineer

• 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
• Statistical Analysis and Exploratory Data Analysis (e.g., descriptive statistics, regression, visualization)
• Developed test methods and verification protocols for software product
• 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
• Data Governance, Access Controls, and PHI Data Handling

Senior Software V&V Engineer, Imaging Systems

Compliance

• Define and execute the long-term regulatory strategy aligned with corporate growth objectives and portfolio expansion
• Architect regulatory strategies enabling independent iteration of AI algorithms distinct from core platforms
• Lead regulatory assessments supporting expansion into broader clinical workflows bridging diagnostic imaging and treatment planning
• Operationalize market access beyond the U.S. (EMEA, GCC), harmonizing technical documentation under an “assess once, submit many” framework
• Establish and approve regulatory policies, standards, and governance models that ensure enterprise-wide compliance and consistency
• Serve as a key advisor to executive leadership on regulatory risk, emerging policy trends, and strategic expansion opportunities
• Lead implementation and optimization of Regulatory Information Management (RIM) systems and integration with eQMS platforms
• Develop internal regulatory intelligence capabilities leveraging AI to monitor evolving global regulations
• Ensure commercial claims remain defensible, traceable to cleared indications, and aligned with global regulatory requirements
• Establish scalable processes, KPIs, and performance metrics to enhance regulatory efficiency, transparency, and predictability
• Develop and manage departmental budgets and long-range resource planning aligned with corporate growth
• Serve as primary executive representative before global regulatory authorities on high-impact strategic matters
• Engage in industry forums and policy discussions influencing regulatory frameworks for AI/ML-enabled medical devices
• Analyze societal, economic, and policy trends to proactively inform Cleerly’s regulatory and business strategies
• Build and mentor a high-performing leadership team (Directors and Senior Managers)
• Partner with HR to develop succession planning, retention strategies, and executive-level capability development
• Lead initiatives requiring alignment across Regulatory, Engineering, Product, Clinical Affairs, Marketing, and Legal
• Reinforce a culture grounded in integrity, transparency, and regulatory excellence consistent with enterprise-level expectations

Vice President, Regulatory Strategy – Innovation

Manager

• Provide technical expertise to internal teams and external clients
• Manage technical escalations and complaints
• Communicate with teams, departments, and clients
• Assist the training department when required
• Manage essential Technical projects
• Evaluate quality and turnaround time trends
• Collaborate cross-functionally with all other Core Lab departments and external teams

Technical Manager – US Core Lab

Full-stack Engineer

• Develop scalable backend services (Node.js, TypeScript) and performant user-facing applications (React, Next.js).
• Design extensible system architectures and make pragmatic trade-offs that balance performance, security, and maintainability.
• Own full lifecycle delivery of complex features, from architectural planning and API design to UI implementation and post-release observability.
• Ensure high availability and observability of our services; improve alerting, logging, and incident response across the stack.
• Set and uphold strong engineering standards via code reviews, technical mentorship, and design documentation.
• Partner with product, design, and stakeholders to align engineering with business goals and user needs.
• Lead technical design reviews and system decomposition efforts across teams.
• Proactively identify risks and gaps in operational or architectural resilience, and drive durable improvements.
• Collaborate closely across engineering to reduce knowledge silos and ensure continuity in critical systems through cross-training and documentation.
• Participate in on-call rotations and lead post-incident reviews, driving long-term reliability improvements across systems.

Senior Software Engineer, Operational Systems Team

• Build and enhance fullstack applications using React, TypeScript, and Node.js, delivering both usability and performance.
• Work cross-functionally to translate customer feedback into intuitive, high-impact solutions.
• Drive features from concept to production, including design, development, testing, deployment, and ongoing monitoring.
• Deliver reliable, observable enterprise features that maintain uptime and build customer trust.
• Conduct code reviews, mentor teammates, and raise the technical bar across the team.
• Participate in on-call rotations and contribute to post-incident reviews to drive long-term reliability.

Senior Software Engineer – Contextual Launch, Enterprise Experience

QA Engineer

• Design, develop, and maintain automated test frameworks and test cases using Python
• Integrate automated tests with CI/CD pipelines for continuous testing and feedback.
• Contribute to test planning, test case design, test documentation, and risk assessment.
• Drive defect prioritization and perform impact analysis
• 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
• Continuously evaluate our testing workflow and drive improvements to increase efficiency and product quality
• Stay up-to-date with the latest trends and advancements in QA and share knowledge with the team

Senior Software Quality Engineer, Imaging Systems

Operations

• Triage incoming cases, resolve issues, and handle requests.
• Supports daily workflow processes to include the lifecycle of a scan.
• Triage and investigate client needs along with Imaging Services requests.
• Interface with Sales, Clients, Technology, Medical Affairs, Operations, Marketing and Imaging Services teams.
• Monday - Friday rotating shifts 7 am ET - 4 pm ET. and 8 am ET - 5 pm ET.
• 5-10% Travel expected.

Imaging Operations Support – Eastern Time Zone

Director

• Lead and manage market research initiatives to gather actionable insights on customer needs, market trends, and competitive landscape.
• Design and execute quantitative and qualitative research projects using a variety of research techniques to provide a comprehensive understanding of the market.
• Communication and storytelling– Strong writing skills where you can craft a story around data insights and clearly communicate key points in a succinct manner.
• Maintain vendor relationships and work with Procurement to continuously streamline and improve the ability of business teams to gain insights from customers, physicians, patients, and other healthcare system stakeholders as required.
• Lead and contribute to competitive monitoring initiatives, derive and distill insights on both traditional and emerging competitors around the world, and communicate these insights in a clear, structured, and timely manner.
• Analyze data to identify key insights and opportunities for Cleerly’s products and services.
• Work across the organization to develop, grow and optimize a Voice of the Customer plan/program.
• Collaborate with cross-functional teams to ensure the VoC plan aligns with product development, marketing strategies, and sales efforts.
• Monitor and evaluate customer feedback to drive continuous improvement in product offerings and customer experience.
• Build and maintain advanced analytics capabilities to support data-driven decision-making.
• Create and present detailed reports and dashboards that communicate key insights and recommendations to stakeholders.
• Track and measure the impact of customer insights on business performance and strategic initiatives.
• Partner with product, marketing, and sales teams to integrate customer insights into product roadmaps, marketing campaigns, and sales strategies.
• Work closely with the data science team to leverage AI and machine learning techniques for deeper customer insights.
• Foster a culture of customer-centricity across the organization.
• Lead and mentor a team of insights and analytics professionals, fostering a collaborative and innovative environment.
• Provide training and development opportunities to enhance team capabilities and ensure best practices are followed.

Director, Market Research – Customer Insights

• Act as the design quality engineering lead on software development project teams, providing guidance and oversight to ensure compliance with the Quality Management System (QMS) and external regulations.
• Review and approve design and development documentation, including user needs, requirements specifications, software architecture, and verification & validation (V&V) plans, protocols, and reports.
• Ensure all design control activities are compliant with ISO 13485, IEC 62304, and FDA 21 CFR Part 820.
• Facilitate, document, and maintain risk management activities according to ISO 14971 throughout the product lifecycle, from initial concept through post-market surveillance.
• Collaborate with engineering teams to ensure test methodologies are robust, effective, and well-documented for verifying and validating the software medical device.
• Maintain the Design History File (DHF) for assigned projects, ensuring they are complete, accurate, and ready for audits and regulatory inspections.
• Provide quality oversight for the software development lifecycle (SDLC) within an agile development environment, ensuring quality is built into the process.
• Participate in design reviews, technical reviews, and other project meetings to ensure quality considerations are addressed and integrated.
• Participate in software issue triage to determine risk of issues to the medical device and aid in development prioritization.
• Support the investigation of design-related complaints and contribute to Corrective and Preventive Action (CAPA) activities as required.
• Team leader who, in conjunction with management, designs and drives team-wide and company-wide training in the above areas.

Principal Design Quality Engineer

• Define and execute the long-term regulatory strategy aligned with corporate growth objectives and portfolio expansion
• Architect regulatory strategies enabling independent iteration of AI algorithms distinct from core platforms
• Lead regulatory assessments supporting expansion into broader clinical workflows bridging diagnostic imaging and treatment planning
• Operationalize market access beyond the U.S. (EMEA, GCC), harmonizing technical documentation under an “assess once, submit many” framework
• Establish and approve regulatory policies, standards, and governance models that ensure enterprise-wide compliance and consistency
• Serve as a key advisor to executive leadership on regulatory risk, emerging policy trends, and strategic expansion opportunities.
• Lead implementation and optimization of Regulatory Information Management (RIM) systems and integration with eQMS platforms
• Develop internal regulatory intelligence capabilities leveraging AI to monitor evolving global regulations

Vice President, Regulatory Strategy and Innovation

Product Manager

• Lead the product roadmap for innovation products aligning with market demand, customer needs and company goals.
• Apply first principles thinking to understand complex clinical problem spaces and map them to effective product solutions and revenue opportunities.
• Engage with internal and external stakeholders, such as clinicians and engineering, to shape the product vision and direction; establish the voice of the customer funnel.
• Write clear business and functional requirements that support development efforts while ensuring clinical relevance and regulatory alignment.
• Understand the domain of diagnostic and prognostic care pathways for heart disease to guide product decisions.
• Prioritize features and balance trade-offs between performance, feasibility, and business impact.
• Collaborate with program management, regulatory, and engineering teams on implementation, from design and development reviews to launch, ensuring timely and high-quality delivery.
• Work closely with product management peers, marketing and leadership teams to develop and support the go-to-market strategy.
• Define, track, and interpret key product metrics to drive future product iteration, inform decisions and drive continuous improvement.
• Partner with downstream marketing and sales team on product detail and messaging and support of initial implementation of products in the field at key customer accounts.