RapidAI
RapidAI is the global leader in using AI to combat life-threatening vascular and neurovascular conditions. RapidAI is empowering physicians to make faster decisions for better patient outcomes, leading the next evolution of clinical decision-making and patient workflow. Based on intelligence gained from over 10 million scans in more than 2,000 hospitals in over 60 countries, the Rapid® platform transforms care coordination, offering care teams a level of patient visibility never before possible. RapidAI – where AI meets patient care.
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Engineering
hybrid: USA
Salary range $182,000 - $195,000
added Thu Aug 17, 2023
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RapidAI has revolutionized stroke care with our award-winning products, we are the pioneer and market leader in our field and we’re just getting started! Our products are in constant use by clinical teams to coordinate the treatment of patients in hospitals across the globe.
We process data for 1/2 of all stroke cases in the United States and a large number of stroke cases in other countries of the world, including Switzerland, Japan, Australia and Brazil.
We're looking for a passionate, seasoned technical leader to help shape our future!
What you will do:
- Work and empower a top-notch technical team to drive ambitious engineering projects for the Rapid Platform, Web Portals and associated systems
- Collaborate with Product Managers to ensure that the right people are building the right things
- Work alongside Program Managers and other stakeholders to build a delivery roadmap, set expectations, communicate status, and be accountable for your team's delivery
- Collaborate with other technical leaders to drive a consistent, streamlined approach to software delivery
- Drive continuous process improvement to increase output while maintaining software quality & high morale
- Collaborate with a diverse global team, including team members in India, to drive cross-functional initiatives and achieve organizational goals, necessitating flexibility to work across different timezones
What you bring:
- Bachelor’s degree in CS/EE or equivalent industry experience
- 5+ years of experience with managing Software Engineering teams
- 10+ years of experience with commercial Software Engineering
- 4+ years of experience with cloud computing (AWS)
- Experience in Java, GoLang or any modern programming language
- Experience in modern web frontend stacks such as Angular or React is a definite plus
- Excellent interpersonal and communication skills
- Proven ability to build and maintain high performing software teams.
- Excellent personal organization skills & attention to detail
- Experience with web portal developments
- Med-tech or Healthcare experience
- Experience in a regulated software environment e.g. medical device, aerospace, defense, automotive
- Experience with DICOM, HL7 or other medical data formats & protocols
Bonus Skills:
What we offer you:
- RapidAI pays 100% for employee coverage & 75% for your dependent coverage for medical, dental & vision premiums.
- Medical Benefits – We offer a range of policies through TriNet
- Life Insurance/AD&D is 1X times your annual salary
- We pay 100% for Short and Long Term Disability.
- Healthcare and Dependent care flexible spending accounts are available
- A 401k plan is offered through Empower
- RapidAI provides $100 a month for internet/cell/phone services.
- We have 10 company paid holidays!
- RapidAI has a flexible vacation policy. We urge employees to take vacation! Vacation allows employees to renew, reinvigorate, and rejuvenate.
- Equity - Stock Options
- Incentive Compensation
- And most importantly - You are joining an awesome team!
Time Off:
Other Cool Benefits:
Compensation - The salary range target for the role described in this job description is $182,000 - $195,000. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Apply to RapidAI
The primary accountabilities of the Full Stack Engineer are the creation and maintenance of web based applications. Secondary accountabilities include cloud platform administration and consulting with business stakeholders.
What you will do:
- Develop web applications sourcing data from vended as well as in-house developed APIs.
- Assist in the creation of application architecture elements to enhance & extend RapidAI’s data storage & acquisition, processing, and visualization capabilities.
- Collaborate with QA engineering and other teams to ensure compliance with respect to FDA and other regulatory body requirements.
- Leverage git to manage code across the development lifecycle inclusive of pull requests, merges, commits and reviews.
- Establish CI/CD pipelines to deploy code leveraging modern CI/CD tools and methodologies.
- Collaborate with RapidAI’s DevOps team to develop Infrastructure as Code deliverables.
- Automate testing through the creation of Unit and Integration test routines.
- Assist in management and administration of public cloud infrastructure inclusive of componentry hosted by AWS, Google / Looker and Snowflake.
- Build front end UI leveraging Vue.js, Angular, and/or React.
- Build backend systems inclusive of FastAPI, relational & non-relational data stores, and supporting cloud infrastructure.
- Provide 3rd level support to resolve customer facing issues in collaboration with Professional Services, DevOps and other Engineering teams.
- Provide for application security through integration with Okta and adoption of secure coding practices.
- Author technical documentation.
- This position does not have direct reports.
- Perform any other related activities assigned by reporting manager.
What you bring:
- Bachelor’s Degree (Graduate Degree preferred) related to computer science; other STEM disciplines will be considered.
- 7-10+ years experience in full stack web application development, preferably in a start-up environment.
- Exceptional communication skills relevant to engaging a globally distributed and culturally, geographically, & time zone diverse team.
- Expertise developing backend systems leveraging Python (preferred) or Go.
- Expertise developing web based front end user interfaces leveraging JavaScript / TypeScript.
- Expertise in SQL as applied to the creation and retrieval of data sets to enable API development.
- Expertise in GitOps inclusive of code management and PR processing.
- Experiencing developing cloud hosted applications.
- Experiencing leveraging container based technologies inclusive of Docker, Kubernetes, Helm and AWS EKS.
- Expertise authoring analytic dashboards using Looker or similar (Tableau, Sisense, etc).
- Familiarity with Jenkins, GitHub Actions, CircleCI, TravisCI, CodeFresh (preferred) or other CI/CD platform.
- Familiarity using Terraform (preferred), Pulumi and/or AWS CloudFormation.
- Understanding of Agile software development practices including common Scrum/Kanban SDLC management platforms such as Jira, Asana, YouTrack or similar.
- Experience working with on premises (Linux preferred) and public cloud (AWS preferred) compute environments.
- Experience assisting with the management of cloud based systems such as Google Looker, Snowflake, and AWS.
- Familiarity with EMR and PACS and other clinical systems.
- Familiarity with Salesforce, Grafana and Kubernetes APIs.
- Demonstrated ability to prioritize and deliver on multiple responsibilities simultaneously.
- Understanding of HIPAA, GDPR and other regulatory frameworks guiding the use of personally identifiable datasets.
- Ability / willingness to participate in meetings during morning office hours in Pacific time zone (HQ is in Silicon Valley, California).
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Engineering
hybrid: USA
Salary range $200,000 - $208,000
added Tue Oct 24, 2023
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What you will do:
- Provide technical leadership and mentorship for other engineers on the team
- Write high quality and maintainable code
- Design and build impactful technical solutions and own them through the entire development lifecycle
- Lead engineering projects and initiatives, including scoping, planning, and execution
- Collaborate cross-functionally with product management, design, and other engineering teams
- Research and evaluate new technologies and techniques for potential adoption
- Establish architecture plans, conventions, standards, and best practices
- Identify areas for improving code quality, performance, scalability, and stability
- Conduct code reviews and ensure code quality, test coverage, and documentation
- Ensure the engineering team understands the business direction and how each individual engineer’s work contributes towards the big picture of the product line and company offerings
What you bring:
- 15+ years of experience in software development /engineering and demonstrated engineering team leadership
- Bachelors’ Degree or equivalent
- High level of skill in at least one general-purpose backend language and one frontend language, but willingness to work with other languages if required
- High level of knowledge of HTTP as well as API and database schema design
- High level of distributed system design skill
- Creating platforms, reusable libraries, and utilities wherever applicable
- Writing high-quality code that is modular, functional, and testable
- Troubleshoot issues effectively in a distributed architecture
- Communicate, collaborate and work effectively in a global environment
- Solid analytical and reasoning skills for design, troubleshooting and root cause analysis
- Great communication skills with technical and non-technical teams
What we offer you:
- RapidAI pays 100% for employee coverage & 75% for your dependent coverage for medical, dental & vision premiums.
- Medical Benefits – We offer a range of policies through TriNet
- Life Insurance/AD&D is 1X times your annual salary
- We pay 100% for Short and Long Term Disability.
- Healthcare and Dependent care flexible spending accounts are available
- A 401k plan is offered through Empower.
- RapidAI provides $100 a month for internet/cell/phone services.
- We have 10 company paid holidays!
- RapidAI has a flexible vacation policy. We urge employees to take vacation! Vacation allows employees to renew, reinvigorate, and rejuvenate.
- Equity - Stock Options
- Incentive Compensation
- And most importantly - You are joining an awesome team!
Time Off:
Other Cool Benefits:
Compensation - The salary range target for the role described in this job description is $200,000 to $208,000. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Engineering
hybrid: USA
Salary range $150,000 - $160,000
added Thu Aug 17, 2023
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We are looking for a Software Engineer who is interested in straddling programming & architecture that can scale our technology to greater heights as we re-define an industry impacting human life.
What you will do:
- Work with a global top-notch technical team to drive ambitious engineering projects for the Rapid Platform, Web Portals and associated systems
- Build scalable, reliable, highly available, multi-tenant, cloud systems
- Exercise AWS best practices
- Collaborate with clinical, R&D, engineering and regulatory teams within product-focused projects
- Troubleshoot and resolve faults in any environment (note: no routine on-call)
What you bring:
- Bachelor’s degree in CS/EE or equivalent industry experience
- 2-5 years of experience with commercial Software Engineering
- 2+ years of experience with cloud computing (AWS)
- Experience in Java, GoLang or any modern programming language
- Experience in modern web frontend stacks such as Angular or React is a definite plus
- Excellent interpersonal and communication skills
- Med-tech or Healthcare experience
- Experience in a regulated software environment e.g. medical device, aerospace, defense, automotive)
- Experience with DICOM, HL7 or other medical data formats & protocols
Bonus Skills:
What we offer you:
- RapidAI pays 100% for employee coverage & 75% for your dependent coverage for medical, dental & vision premiums.
- Medical Benefits – We offer a range of policies through TriNet
- Life Insurance/AD&D is 1X times your annual salary
- We pay 100% for Short and Long Term Disability.
- Healthcare and Dependent care flexible spending accounts are available
- A 401k plan is offered through Empower.
- RapidAI provides $100 a month for internet/cell/phone services.
- We have 10 company paid holidays!
- RapidAI has a flexible vacation policy. We urge employees to take vacation! Vacation allows employees to renew, reinvigorate, and rejuvenate.
- Equity - Stock Options
- Incentive Compensation
- And most importantly - You are joining an awesome team!
Time Off:
Other Cool Benefits:
Compensation - The salary range target for the role described in this job description is $150,000 to $160,000. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Apply to RapidAI
What you will do:
- Primary focus will be on developing components (DICOM Viewer, DICOM Backend etc.) and implementing them following well-known React.js workflows (such as Flux or Redux).
- Ensure that these components and the overall application are robust and easy to maintain.
- Coordinate with the rest of the team working on different layers of the infrastructure. Therefore, a commitment to collaborative problem solving, sophisticated design, and quality product is important.
- Deliver software on time and to specification within an Agile framework using Scrum methodologies
- Participate in code reviews as needed to ensure quality and secure coding practices
- Work directly with business and technology leadership to manage end user expectations
- Help create technical specifications, system documentation and other project deliverables
Tech Stack:
- DICOM
- ReactJS
- Web Application Development & Deployment - UI/CSS etc
- Performance Tuning
- Docker/Containerization basic
- Troubleshooting
- iOS native basic
- DICOM Open Source experience
- Java
- Basic Linux/Unix knowledge
- Cloud Basic
What you bring:
- Experience with common front-end development tools such as Babel, Webpack, NPM, etc.
- Ability to understand business requirements and translate them into technical requirements
- A knack for benchmarking and optimization
- Familiarity with code versioning tools {{such as Git, SVN, and Mercurial}}
- Familiarity with RESTful APIs
- Familiarity with DICOMWeb, HL7, FHIR etc.
- Possess excellent problem-solving skills with an emphasis on continuous improvement
- Healthcare Experience
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Apply to RapidAI
The job market is hot and skilled engineers such as yourself have no shortage of opportunities, but how many companies offer the chance to directly save & improve people’s lives through technology? We do!
RapidAI has revolutionized stroke care with our award-winning products, we are the pioneer and market leader in our field and we’re just getting started!
Our mobile app is in constant use by clinical teams to coordinate the treatment of patients in hospitals across the globe.
We process data for 1/2 of all stroke cases in the United States and a large number of stroke cases in other countries of the world, including Switzerland, Japan, Australia and Brazil.
A top-tier mobile experience is central to our vision - we’re looking for passionate engineers to join our growing mobile team and build our future
What you’ll be doing
- Work closely with a small group of passionate engineers, designers, product managers and domain experts
- Design and build impactful technical solutions and own them through the entire development lifecycle
- Communicate your ideas to invite feedback and build consensus
- Write high quality, maintainable code
- Support and challenge yourself and your peers to continuously improve engineering skills and practices
- Work with bleeding edge iOS stacks like SwiftUI, Combine and Swift concurrency
What you’ll need
- Bachelor’s or Master’s degree in CS/EE/IT or equivalent industry experience
- 8+ years of general professional software engineering experience
- 5+ years of professional experience building mobile applications for native iOS
- Fluent in building UI programmatically, e.g., Auto layout (constraints), SwiftUI
- Professional experience in Reactive programming paradigm, using frameworks such as RxSwift, Combine etc.
- High level of skill in Swift programming
- Deep knowledge of the iOS SDK and device capabilities
- A good understanding of the unique challenges of mobile development (intermittent connectivity, push notifications, app version/device/OS fragmentation etc.)
- Good inter-personal and communication skills, and a desire to work in a supportive team environment.
- A good understanding of dependency management
- Understand how to setup, write and run automated tests, e.g., unit, integration
- High level of skill in git and GitHub
- Having interest in emerging technologies and new ways of doing things
Optional Bonus skills
- Experience with automated testing and CI/CD for iOS apps
- Experience in using Combine and/or SwiftUI
- Med-tech or Healthcare experience
- Experience in a regulated software environment e.g. medical device, aerospace, defense, automotive
- Experience with DICOM, HL7 or other medical data formats & protocols
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Professional Services
hybrid: USA
Salary range $33,000 - $45,500
added Thu Sep 21, 2023
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At RapidAI, we believe in leveraging cutting-edge technology and research to impact millions of lives. We’re looking for a high-energy team member who’s excited to be at the forefront of stroke research. The successful candidate will work across multiple teams to help ensure we continue to deliver the best patient care to people all around the world.
What you will do:
- Perform segmentation of medical images of various modalities as required by the Surgical Preview software system.
- Operate the Surgical Preview software system to process and analyze segmentation outputs and deliver results for customers and to support research/clinical studies.
- Assist with case/project progress tracking.
- The candidate must have initiative and have good judgement in knowing when to make decisions independently and when to refer them to supervision.
What you bring:
- Knowledge/experience of medical image segmentation, cerebral/cerebrovascular anatomy, Windows OS, and required software (e.g Materialise Mimics).
- BS degree in technical/engineering or related field with a focus on life sciences/medical devices preferred or equivalent experience.
- Strong English writing and speaking skills
- Ability to work 35 hrs/wk
- Willingness and ability to work afternoon, evenings, and/or weekend shifts
- Must be eligible to work in the US without current or future visa sponsorship
Compensation - The salary range target for the role described in this job description is $33,000 to $45,500. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Apply to RapidAI
The Technical Services Specialist is responsible for first and second level support for all RapidAI software and hardware. This position provides effective diagnostic evaluation of end- users’ needs. The candidate must use good judgment and timeliness in responding to and resolving all issues or complaints to the customers’ satisfaction.
Resolution includes but is not limited to the following: identify, research, and resolves technical problems, timely response to telephone calls, email and personnel requests for technical support. The position also requires accurate documentation and tracking, and monitoring the problem to ensure a timely resolution.
This team may also be called upon to deliver technical training and support needs for RapidAI personnel and customers.
What you will do:
- Provide quality service to RapidAI's customers in all assigned tasks, while upholding iSchemaView values at all times
- Support all internal users and external customers with product training, knowledge and expertise.
- Provide solutions in a timely fashion for issues that may arise with all RapidAI products.
- Log and track support calls in the designated RapidAI system(s) prioritize and escalate jobs as required to ensure customer satisfaction.
- Identify trends in the support calls and develop documentation to address these most-often reported problems and issues. Notify management of increasing trends, unusual activity or repeated activity.
- Brief customers as well as management on the status of current resolution efforts and attend daily/weekly meetings as requested or required.
- Recommends means for product or system improvements including procedural steps, increased training, and enhanced documentation.
- Access Application updates, OS Updates, and FAQ’s resources on the Intranet to assist.
- Assist other teams to initiate, design and manage effective support solutions as directed by our business needs.
- Effectively communicate the ideas, expectations, and goals while working with and through others to achieve desired result.
- Involve other team members to establish best practices/decisions
- Act independently when required
What you bring:
- Minimum of one to three years experience in a technical support environment
- Diagnostic and analytical skills for software and general IS application knowledge
- Strong computer literacy skills with an emphasis on software knowledge, installations and use. Linux OS, VPN protocols, LAN.WAN protocols, and internet protocols
- Ability to multitask - Sense of urgency; maintain a positive attitude
- Excellent telephone presence with organized follow-up skills
- Ability to be proactive and able to take direction and establish ownership of projects.
- Excellent English verbal and written communication skills
- Strong customer focus; service oriented attitude
Working Hours:
- Hours may vary and will require evening and weekend work as directed by the company needs.
- Nights weekends, and flexible hours is a must.
- This can be a full-time or part-time position
Compensation - The hourly rate target for the role described in this job description is $40.00 - $60.00 per hour. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Quality & Regulatory
hybrid: Golden
Salary range $105,000 - $12,000
added Thu Aug 17, 2023
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What you will do:
- Independently perform quality engineering activities related to Software as a Medical Device (SaMD).
- Develop, implement, and maintain standards for software quality processes, systems, and procedures to support the software life cycle.
- Perform design control and risk management activities according to RapidAI’s Quality System.
- Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) and design change control requirements are met.
- Review product requirements for traceability, risk remediation and testability.
- Review verification and validation deliverables for compliance with regulatory requirements.
- Track software problem reports and deviation up to closure.
- Support the development, update, validation, and documentation of software utilized in the testing of SaMD.
- Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
- Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
- Apply knowledge of global regulations and guidance's. Assist in the preparation for and support of regulatory agency and internal audits.
What you bring:
- Bachelor of Science Degree with 8+ years of experience preferred.
- Previous experience working with Quality Management System (ISO 13485 and 21 CFR 820) is preferred.
- Previous experience executing to IEC 62304 in regard to SaMD is preferred.
- Strong organizational and project management skills with an attention to detail and accuracy
- Strong people and communication skills (oral and written).
- Strong work ethic and interpersonal skills.
- Results driven: Focused on individual and team success by being accountable to strict deadlines and holding collaborators accountable.
What we offer you:
- RapidAI pays 100% for employee coverage & 75% for your dependent coverage for medical, dental & vision premiums.
- Medical Benefits – We offer a range of policies through TriNet
- Life Insurance/AD&D is 1X times your annual salary
- We pay 100% for Short and Long Term Disability.
- Healthcare and Dependent care flexible spending accounts are available
- A 401k plan is offered through Empower
- RapidAI provides $100 a month for internet/cell/phone services.
- We have 10 company paid holidays!
- RapidAI has a flexible vacation policy. We urge employees to take vacation! Vacation allows employees to renew, reinvigorate, and rejuvenate.
- Equity - Stock Options
- Incentive Compensation
- And most importantly - You are joining an awesome team!
Time Off:
Other Cool Benefits:
Compensation - The salary range target for the role described in this job description is $105,000 to $120,00. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Quality & Regulatory
hybrid: Colorado
Salary range $108,000 - $120,000
added Thu Aug 17, 2023
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We are looking for an experienced Quality Systems Manager to join our team.
What you will do:
- Manage the Quality Management System through writing and updating procedures and documents related to ISO 13485, 21 CFR 280, MDSAP Regulations, and other world-wide regulations and standards.
- Assist with the transition to new standards and regulations by interpreting the regulation, updating procedures, coordinating audits, and supporting technical documentation and clinical evaluation report updates.
- Assist with keeping Supplier Files up to date and implementing Quality Agreement with applicable vendors.
- Maintain all procedures and documents in an organized and readily available fashion for audits.
- Perform other ISO 13485 and 21 CFR 820 related activities as assigned by reporting manager.
- Arrange, sort and store documents, samples, records as needed.
- This position does not have direct reports.
- Perform any other related activities assigned by reporting manager.
What you bring:
- Bachelor’s degree with five (5) plus years of related experience preferred or seven (7) plus years of experience.
- Previous experience working with Document Control Systems and Quality Management Systems, Regulations, and Standards
- Strong organizational and project management skills, with attention to detail and accuracy
- Strong people and communication skills (oral and written).
- Results driven with a focus on team success by being accountable to strict deadlines and holding collaborators accountable.
What we offer you:
- RapidAI pays 100% for employee coverage & 75% for your dependent coverage for medical, dental & vision premiums.
- Medical Benefits – We offer a range of policies through TriNet
- Life Insurance/AD&D is 1X times your annual salary
- We pay 100% for Short and Long Term Disability.
- Healthcare and Dependent care flexible spending accounts are available
- A 401k plan is offered through Empower.
- RapidAI provides $100 a month for internet/cell/phone services.
- We have 10 company paid holidays!
- RapidAI has a flexible vacation policy. We urge employees to take vacation! Vacation allows employees to renew, reinvigorate, and rejuvenate.
- Equity - Stock Options
- Incentive Compensation
- And most importantly - You are joining an awesome team!
Time Off:
Other Cool Benefits:
Compensation - The salary range target for the role described in this job description is $108,000 to $120,000. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Quality & Regulatory
hybrid: Denver
Salary range $99,000 - $11,000
added Thu Aug 17, 2023
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At RapidAI, we believe in leveraging cutting-edge technology and research to impact millions of lives. Our software products enhance doctors’ capabilities across hospitals worldwide to respond to and make the best decisions for patients quickly. We are looking for a high-energy employee who is excited to be at the forefront medical device software development. The successful candidate will meet the criteria defined below, and in doing so, will help deliver the best patient care to patients all around the world.
What you will do:
- Assemble, distribute, store, track and retrieve information pertinent to the regulatory process, including the regulatory submissions process
- Author and publish electronic submissions
- Manage requests from foreign government and/or distributors as needed
- Research, analyze and communicate information pertaining to the appropriate regulatory pathway for new or modified products
- Provide regulatory direction to development project teams as a core team member; helps develop regulatory strategy for new products
- Evaluate risk of proposed regulatory strategies; may offer solutions
- Review proposed labeling for compliance with applicable global regulations
- Review and evaluate promotion and advertising material for compliance with applicable regulations
- Review proposed product changes for impact on regulatory status of the product
- Communicate with regulatory and governmental agencies
- Labeling and promotion materials review
- Apply FDA regulations to business practices and provides regulatory input, advice and guidance to design teams
- Assist quality team – including but not limited to training and document control
- Work with external RA partners to maintain and update foreign registrations
- This position does not have direct reports.
- Perform any other related activities assigned by reporting manager.
What you bring:
- Strong written/verbal communication and interpersonal skills
- Strong attention to detail; ability to multi-task and balance competing priorities
- Knowledge of overall business environment, the SaMD industry, and the marketplace
- Ability to learn and stay abreast of regulations pertinent to medical devices
- Ability to building relationships between Regulatory Affairs and other areas of the organization: ability to communicate effectively at all levels
- Knowledge of FDA, EU, and other regulatory body regulations
What we offer you:
- RapidAI pays 100% for employee coverage & 75% for your dependent coverage for medical, dental & vision premiums.
- Medical Benefits – We offer a range of policies through TriNet
- Life Insurance/AD&D is 1X times your annual salary
- We pay 100% for Short and Long Term Disability.
- Healthcare and Dependent care flexible spending accounts are available
- A 401k plan is offered through Empower
- RapidAI provides $100 a month for internet/cell/phone services.
- We have 10 company paid holidays!
- RapidAI has a flexible vacation policy. We urge employees to take vacation! Vacation allows employees to renew, reinvigorate, and rejuvenate.
- Equity - Stock Options
- Incentive Compensation
- And most importantly - You are joining an awesome team!
Time Off:
Other Cool Benefits:
Compensation - The salary range target for the role described in this job description is $99,000 to $110,00. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Quality & Regulatory
hybrid: Golden
Salary range $200,000 - $245,000
added Tue Oct 24, 2023
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The Vice President, Quality Assurance is a key leadership role responsible for developing, implementing, and maintaining the quality management system to ensure the highest level of product quality and regulatory compliance. This role involves leading the Quality Assurance function, a team of quality professionals, defining quality standards, and collaborating across departments to achieve organizational goals, establishing quality processes and monitoring metrics for compliance. This role involves overseeing the quality management system, quality compliance, process improvement, and quality control initiatives meeting all worldwide markets.
What you will do:
- Quality Management System (QMS) Leadership:
- Monitor, implement changes, and maintain the organization's QMS to meet quality objectives and requirements worldwide.
- Establish and monitor key performance indicators (KPIs) to measure the effectiveness of the QMS.
- Manage the core quality system activities and deliverables to maintain compliance to international medical device regulations and certifications.
- Formulate, write and maintain procedures, specifications and standards for the quality control of ISV products to ISO 13485, MDR and 21 CFR 820.
- Maintain training system records and processes for the QMS required training.
- Maintain supplier management records and files.
- Provide guidance to employees on quality system quality regulation requirements.
- Maintain the defect management records and processes.
- Stay current with relevant industry regulations and standards.
- Ensure the organization's compliance with applicable regulatory requirements, such as FDA, ISO, or other industry-specific standards.
- Stay current with relevant industry regulations and standards.
- Ensure the organization's compliance with applicable regulatory requirements, such as FDA, ISO, or other industry-specific standards.
- Stay current with relevant industry regulations and standards.
- Ensure the organization's compliance with applicable regulatory requirements, such as FDA, ISO, or other industry-specific standards.
- Develop and execute a comprehensive quality assurance strategy aligned with the organization's goals and objectives.
- Identify and mitigate quality risks across the organization.
- Recruit, train, and mentor a high-performing team of quality professionals.
- Set performance expectations, conduct regular performance reviews, and promote professional development.
- Implement effective quality control processes and methodologies to monitor product or service quality.
- Lead investigations and root cause analyses for quality issues and implement corrective and preventive actions (CAPAs).
- Continuously assess and improve quality-related processes and procedures.
- Collaborate with cross-functional teams to optimize workflows and enhance product or service quality.
- Maintain accurate and comprehensive quality documentation, including records of audits, inspections, and quality reports.
- Prepare and present quality-related reports to senior management.
- Effectively communicate quality-related information to internal and external stakeholders, including customers, regulatory agencies, and auditors.
Regulatory Compliance:
Quality Assurance Strategy:
Regulatory Compliance:
Quality Assurance Strategy:
Team Management:
Quality Control:
Process Improvement:
Documentation and Reporting:
Stakeholder Communication:
What you will do:
- Bachelor's degree, preferably in engineering or related discipline. A master's degree is often preferred.
- 15+ years experience in quality assurance and regulatory compliance, with a track record of progressively increasing responsibility.
- 15+ years in progressive Medical Device Quality roles including management of ISO 13485, MDR and 21 CFR 820 QMS.
- Experience in SaMD/SaaS product based companies
- Experience in dealing with representatives from the Food and Drug Administration (FDA) or other auditing/inspection agencies.
- Previous experience in FDA and Notified Body interactions including FDA inspections, MDSAP Audits, ISO Audits, etc.
- Quality discipline certification preferred (e.g., CQA, CQE, CQM, etc.).
- Experience in software engineering practices for SaaS and SaMD products.
- 10 years of people management experience.
- Strong knowledge of industry-specific regulations and standards.
- Excellent leadership and team management skills.
- Effective communication and interpersonal skills.
- Analytical thinking and problem-solving abilities.
What we offer you:
- RapidAI pays 100% for employee coverage & 75% for your dependent coverage for medical, dental & vision premiums.
- Medical Benefits – We offer a range of policies through TriNet
- Life Insurance/AD&D is 1X times your annual salary
- We pay 100% for Short and Long Term Disability.
- Healthcare and Dependent care flexible spending accounts are available
- A 401k plan is offered through Empower
- RapidAI provides $100 a month for internet/cell/phone services.
- We have 10 company paid holidays!
- RapidAI has a flexible vacation policy. We urge employees to take vacation! Vacation allows employees to renew, reinvigorate, and rejuvenate.
- Equity - Stock Options
- Incentive Compensation
- And most importantly - You are joining an awesome team!
Time Off:
Other Cool Benefits:
Compensation - The salary range target for the role described in this job description is $200,000 to $245,000. Final offer amounts depend on multiple factors including but not limited to candidate experience and expertise, geographic location, compensation/equity mix, and market data. This position may also be eligible for additional incentives such as equity awards, short-term incentives, or sales compensation.
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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The European Sales Manager will report to VP of Sales (EMEA) to oversee sales activities within Italy.
What you will do:
- Supports and generates sales to meet or exceed business goals set by the sales organization. Including renewals of existing contract and new customers contracts.
- Collaborate and maintain good relationships with local Distributors.
- Provide customer satisfaction strategies to advance the utilization of ISV products with new and existing customers in your assigned geographies.
- Identify and create sales opportunities with clinicians and administrators to bring awareness and desire to purchase ISV products.
- Understand and educate customers about stroke workflow, disease state and efficiencies gained with software.
- Participate in targeted Association and Society Events related to disease state areas of opportunity as directed by your Manager
- Develop relationships with local societies to increase awareness of brain imaging software and stroke treatment workflow.
- Provide customer feedback input to your Manager, Engineering, and Marketing.
- Collaborate with sales, marketing, implementation, product and engineering to develop and implement action plans for new and existing customer success.
- Identify key physicians, hospital executive and administrators contacts.
- Maintain initial lead progress, contacts, and progress in Saleforce.com.
- Communicate the ISV value message to all accounts in geographic territory.
- Exemplify the highest level of ethical business conduct of ISV.
- Supports or generates sales programs.
- Makes suggestions or independent decisions within the team to affect business strategies and revenue targets.
- Manage or support client relationships.
- Provide administrative support as needed.
- Build partner relationships as assigned.
- The candidate must have initiative and have good judgement in knowing when to make decisions independently and when to refer them to supervision.
What you bring:
- Master’s or Bachelor’s degree in related field preferred.
- 7+ years of management level experience in Sales of Medical Device/Imaging technology
- Outside sales experience preferred, preferably in med tech, stroke, neurovascular or imaging field.
RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.