Heartflow

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Jobs at this company:

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🔥 Regulatory Specialist

Posted about 6 hours ago

📍 United States

💸 90000.0 - 105000.0 USD per year

🔍 Medical Technology

🔧 Requirements

Base knowledge of global regulatory requirements
Project management skills a plus
Demonstrated team collaboration
Excellent communication, writing, and editing skills
Strong Word, Excel, and PowerPoint skills

💡 Responsibilities

Support frequent minor software releases by performing change assessments
Support EU MDR application and maintenance of technical documentation, including clinical evaluation
Collaborate with cross-functional teams to drive regulatory project management activities
Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices
Collaborate with external partners including regulatory agencies, authorized representatives, importers and distributors
Gain experience with US FDA submissions
Provide input to the risk management process to ensure risks are identified and updated during the product life-cycle
Conduct regulatory surveillance and communicate changes in regulations., standards, and guidances
Support Quality System management, as needed
Other relevant duties as assigned
Ability to work in a fast-paced adaptive environment, self-starter, and strong team player

Project ManagementSoftware DevelopmentWritten communicationDocumentationComplianceExcellent communication skillsCross-functional collaborationQuality AssuranceRisk ManagementChange Management

Posted about 6 hours ago

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🔥 Director, Government Affairs (Home-Based)

Posted 1 day ago

💸 180000.0 - 240000.0 USD per year

🔍 Medtech, diagnostics, or digital health

🔧 Requirements

Bachelor's degree in health policy, public health, business, or a related field required; advanced degree (MPH, MPP, MBA, or JD) preferred.
8+ years in health policy, market access, reimbursement, or government affairs within medtech, diagnostics, or digital health. Experience in the federal government a plus.
Strong understanding of US government functions, policies, and legislation including an understanding of US coding, coverage, and payment system and the organizations of HHS/CMS and Congress
Strong analytical and interpersonal skills with the ability to interpret legislation and policy.
Strong interpersonal skills to develop relationships with stakeholders
Established relationships with government officials and regulatory bodies are a plus.

💡 Responsibilities

Build and maintain strong relationships with key legislative and executive branch stakeholders to understand and advocate for Heartflow’s business and policy priorities.
Engage with policymakers, regulatory bodies, and other government stakeholders to promote Heartflow’s interests, focusing on securing favorable policy and reimbursement outcomes.
Develop and manage comprehensive strategies to advocate for Heartflow’s product reimbursement, working closely with the lobbying, legal, and regulatory teams to engage with CMS (Centers for Medicare & Medicaid Services) and HHS (Department of Health and Human Services).
Monitor proposed legislation and regulatory changes, assessing their potential impact on Heartflow, its products, customers, and patients.
Develop and implement comprehensive government relations strategies that align with the organization's objectives.
Ensure the organization's compliance with all relevant lobbying laws and regulations, including managing political contribution strategies.

Posted 1 day ago

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🔥 Director, Program Management - Software

Posted 14 days ago

📍 United States

🧭 Full-Time

💸 180000.0 - 240000.0 USD per year

🔍 Medical Technology

🔧 Requirements

8+ years in software program or project management
Minimum 5 years of management experience
Bachelor's degree in Engineering, Computer Science, or related field
In-depth understanding of regulatory requirements for medical software products
Certification in Project Management or Agile methodologies is a plus

💡 Responsibilities

Oversee creation of program and project plans
Lead team of program and project managers
Identify and manage risks across programs
Collaborate with cross-functional teams
Communicate program status to stakeholders
Ensure compliance with regulatory standards
Establish best practices for project management
Provide leadership and mentorship to team

Project ManagementSoftware DevelopmentAgileCross-functional Team LeadershipComplianceRisk ManagementStakeholder management

Posted 14 days ago

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🔥 Director, Product Management

Posted 22 days ago

💸 180000.0 - 240000.0 USD per year

🔍 Medical Technology

🔧 Requirements

8+ years of experience in product management, with at least 3 years in a leadership role managing product managers, preferably in software as a medical device or digital health products.
Experience working in regulated industries, with a strong preference in the medical device space.

💡 Responsibilities

Lead Key Product Areas: Take ownership of key product areas within our AI-based software solutions. Lead product managers and cross-functional core teams from definition to delivery. Ensure alignment of your product areas with our broader product strategy and business objectives.
Define and Prioritize: Prioritize product initiatives aligned to business goals and customer needs. Deliver clear early product requirements and scope. Efficiently manage the product backlog and defect prioritization.
Product Strategy & Roadmap: Work with the Senior Director of Product and CTO to contribute to the overall product strategy and roadmap, representing your key product area.
Team Leadership: Recruit, lead, and mentor a team of product managers, fostering a collaborative, customer-focused, and high-performance environment.
Cross-Functional Collaboration: Work closely with engineering, design, marketing, customer success, program management, and regulatory teams to deliver successful product outcomes.
Customer & Market Insights: Engage with customers to gather feedback and use market research to shape product decisions.
Regulatory & Compliance Oversight: Ensure the product areas you lead meet necessary medical device regulations and compliance standards.
Measure Product Success: Define and track key product performance metrics, using data to improve and refine product offerings.

Posted 22 days ago

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🔥 Software Engineer, Reporting and Visualization Engineering

Posted 26 days ago

📍 United States, Canada

💸 96000.0 - 170566.0 USD per year

🔍 Medical Technology

🔧 Requirements

Experience working on enterprise web applications
Experience working with front end application development frameworks (Vue3, React)
Experience working with modern front end application development architecture patterns
Demonstrated proficiency in Javascript and Typescript
Excellent communication and collaboration skills
Interest in building cloud-based infrastructures (Amazon Web Services or equivalent) a plus

💡 Responsibilities

Build modern scalable web applications to visualize 2D and 3D data using latest architecture principles
Create tools with Javascript and Typescript to build infrastructure geared towards medical data visualization
Write tests and documentation for the features you’ve implemented
Debug production issues
Support a large-scale system development effort in the medical device industry
Help create the next generation of cutting-edge heart disease diagnostic systems
Be a critical thinker to solve problems efficiently, pragmatically, and continually seek information.
Communicate efficiently and effectively with other team members

Cloud ComputingFrontend DevelopmentJavascriptTypeScriptVue.JsAmazon Web ServicesREST APIReactCommunication SkillsData visualizationSoftware Engineering

Posted 26 days ago

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🔥 Complaint Specialist (Remote)

Posted 27 days ago

📍 United States

💸 65000.0 - 85000.0 USD per year

🔍 Medical Device

🔧 Requirements

Knowledge of US and International regulatory post-market requirements
Critical thinking skills and great attention to detail
Experience with software medical device product preferred
Experience with EDMS - Electronic Document Management System
Excellent communication, documentation and time management skills
Proficient with Salesforce platform preferred
Proficient with Windows, MS Office, Excel and PowerPoint skills

💡 Responsibilities

Assess reports received through multiple customer feedback channels to identify alleged deficiencies
Ensure accurate documentation, evaluation, reporting determination and investigation results
Post-market surveillance and vigilance reporting
Manage timely and compliant complaint records review and closure
Own the complaint tools and processes with a vision towards process improvement and streamlining
Provide post-market metrics and data as needed
Support Quality Management System, as needed
Assist Customer Support and serve as a liaison for complaint escalations
Review of complaint investigations and trends. General understanding of CAPA, NCR, Health Hazard Evaluation and Risk Management.

SalesforceAnalytical SkillsMicrosoft OfficeAttention to detailComplianceExcellent communication skillsCritical thinkingQuality AssuranceRisk ManagementCRMCustomer support

Posted 27 days ago

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🔥 Staff Software Engineer - Full Stack Backend Focused

Posted about 1 month ago

📍 United States

💸 146232.0 - 240922.0 USD per year

🔍 Medical Technology

🔧 Requirements

10+ years of relevant industry experience
Strong proficiency in modern backend (e.g., Python, Java, Go, Django, Flask, or similar) technologies and database technologies (SQL, NoSQL, or similar) understanding of front-end (e.g., Vue.js, JavaScript, React, Angular, or similar) technologies
Proven track record implementing authentication and authorization systems
Strong expertise in distributed systems and microservices architecture
Demonstrated experience in building, deploying large-scale, secure RESTful APIs
Experience driving technical vision and leading architectural decisions; ability to mentor and lead other engineers
Experience with Agile development methodologies and project management tools.
Strong understanding of web security best practices
Experience with DevOps best practices (e.g., CI/CD pipelines).
Experience with or willingness to learn about FDA regulations and compliance requirements for medical software.
Demonstrated ability to work in a fast-paced, collaborative environment.

💡 Responsibilities

Develop secure and robust authentication and authorization workflows
Drive technical decision around identity management and access control
Design and implement scalable backend services and APIs
Identify technology risks and dependencies early to establish mitigation plans
Mentor and guide other engineers in secure backend best practices and OWASP
Lead the architecture of distributed systems and microservices
Building and maintain critical backend infrastructure
Participate in security audits and compliance reviews
Collaborate with InfoSec and AppSec teams on security implementations
Collaborate cross-functionally with key partners in Product Management, Strategy, Operations, and Regulatory to ensure high-quality, high-impact delivery of innovative software projects

Backend DevelopmentLeadershipPythonSQLAgileDjangoFlaskJavaKubernetesSoftware ArchitectureAlgorithmsAPI testingData StructuresGoPostgresNosqlCI/CDRESTful APIsMentoringDevOpsMicroservicesComplianceJSON

Posted about 1 month ago

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🔥 Clinical Trial Manager

Posted about 1 month ago

💸 85000.0 - 140000.0 USD per year

🔍 Medical Technology

🔧 Requirements

Bachelor’s degree in science or health related field
Demonstrated 5 years minimum relevant experience required
Experience in cardiovascular medical device clinical research a plus
Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
Excellent written and oral English communication skills required
Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint

💡 Responsibilities

Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
Participates in and leads process improvement activities within the department and cross functionally, including SOP development
Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
Perform other duties as required for successfully completing studies, as necessary

Posted about 1 month ago

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🔥 Program Manager

Posted about 2 months ago

📍 United States

💸 120000.0 - 176301.0 USD per year

🔍 Medical Technology

🔧 Requirements

Minimum of 6 years experience with strong preference towards experience in a software and medical industry.
Understanding of and experience with Agile development at scale.
Experience with regulated SaaS products and/or software-as-a-medical-device (SAMD) preferred.
Experience working with JIRA preferred.

💡 Responsibilities

Point person for multiple cross-functional projects.
Lead detailed planning, coordination, execution, and delivery of multiple cross-functional projects.
Recognize and coordinate dependencies of multiple cross-functional projects, ensuring coordination occurs early and often.
Establish, maintain, and communicate plans for associated multiple cross-functional projects.
Communicate on behalf of project managers when required.
Hold team members accountable, set clear performance standards and goals, resolve performance issues, and keep teams engaged and on task.
Coach scrum teams and peers on scrum best practices.
Introduce new initiatives or concepts to the project teams.
Can represent product development in audits and is able to demonstrate traceability and compliance with written procedures for all product development efforts and releases.
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.

Project ManagementSoftware DevelopmentAgileProduct ManagementSCRUMProject CoordinationJiraCross-functional Team LeadershipProduct DevelopmentCommunication SkillsCI/CDProblem SolvingAgile methodologiesRESTful APIsOrganizational skillsComplianceRisk ManagementStakeholder managementSoftware EngineeringChange ManagementSaaS

Posted about 2 months ago

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🔥 Senior Software Engineer, ML Engineering/ML Ops

Posted about 2 months ago

📍 United States

🧭 Full-Time

💸 133859.0 - 175479.0 USD per year

🔍 Medical Technology

🔧 Requirements

Bachelor's/Master’s degree in relevant field
5+ years relevant experience
Proficiency in programming languages (Python, C++)
Familiarity with ML frameworks (PyTorch, Scikit-learn)
Experience with cloud services (AWS, GCP, Azure)
Knowledge of containerization technologies (Docker)

💡 Responsibilities

Design and build ML infrastructure
Maintain tools for ML development
Collaborate with engineers and researchers

AWSDockerPythonGCPMachine LearningPyTorchCI/CD

Posted about 2 months ago

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