Belong @ TeraRecon

Must-Have Requirements:

• 5+ years developing 2D/3D image processing and Machine Learning algorithms for image manipulation, denoising, segmentation, and classification. Familiarity with Bayesian, Deconvolution and Regularization methods is required.
• 3+ years of developing AI-based software involving one or more of the following areas:
  • Natural Language Processing
  • Machine Learning
  • Pattern Recognition
  • Machine Vision
  • Image Analysis
  • Image Segmentation
• 5+ years of experience in C++ (Visual C++).
• 3+ years of experience in Python.
• Strong mathematical and analytical skills. Familiarity with PDE (Partial Differential Equations).
• Team player who enjoys working in a fast-paced environment.

Desired Requirements:

• Experience of developing end-to-end ML/AI solutions from design to deployment.
• 1+ year of experience in C# (also in .NET framework 2.0), windows forms, Managed C++.
• 3D programming experience (geometry, volumetric and surface rendering).
• Algorithm optimization experience (multi-threading, strength reduction, bottleneck identification, data structures)
• Experience of working with medical imaging data such as CT, MRI, and Ultrasound.

Education:

• Masters or Ph.D. in electrical engineering (EE), computer science (CS), applied physics, applied mathematics, biomedical engineering, health information science, or related discipline or equivalent industry experience.

Responsibilities:

Regulatory Submissions

• Review deliverables prior to inclusion in regulatory submissions. Compile, submit, and review deliverables of regulatory filings to regulatory authorities and country representatives.
• Serve as point of contact for regulatory agency requests for additional information.
• Identifies the need for new regulatory procedures and participates in development and implementation.
• Review process changes and determine impact to regulatory filings, and if regulatory agency notification is required.
• Trains stakeholders on current and new regulatory requirements to ensure organization-wide compliance.

Product Development & Registrations (Localization)

• Identifies, monitors and submits applicable reports (e.g., Serious Adverse Events) or notifications (e.g., changes in manufacturing) to regulatory authorities during the clinical research process.
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
• Monitors the progress of the regulatory authority review process through appropriate communication with the agency.
• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
• Works with cross functional teams for interactions with regulatory authorities including panel meetings and advisory committees

Postapproval and Post Market

• Develops, implements, and monitors processes involved with maintaining annual licenses, registrations and listings.
• Reviews and approves labeling, advertising and promotion to ensure regulatory compliance.
• Assures postmarket regulatory requirements are met (e.g., maintains systems to trigger reporting, provide postmarket required reports, supplemental submissions and other postmarketing commitments.)
• Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge.
• Participates in implementation of regulatory strategy and processes for handling recalls and communication to stakeholders (e.g., Dear Healthcare Professional letters, patient letters, distributor letters, and health authorities).
• Reports product safety issues to regulatory authorities as required, to comply with local, regional and global regulations.
• Provides regulatory support and input and appropriate follow-up for inspections and audits

Qualifications:

• 2-4 years in global regulatory submissions and listings for medical device industry
• 2-4 years in adverse event determination and reporting
• Experience with software as a medical device a plus
• Experience and knowledge of product and process regulatory compliance
• Experience with CMS and FDA parallel reviews a plus
• Experience with FDA Digital Health Software Precertification (Pre-Cert) Program a plus

Education:

Bachelor’s Degree required or equivalent experience

Responsibilities:

• Defining and documenting business requirements & functional specifications.
• Prepare SOWs and workflow diagrams.
• Coordinating project and workflow management with design, development and QA teams.
• Prioritizing tasks and effectively managing day-to-day issues.
• Strong analytical, tactical, organizational, multi-tasking and administrative skills
• Cooperating with customer to complete deployment project
• Ensuring project deliverables are strategically aligned with business objectives
• Defining, estimating, and planning project tasks with inter-dependencies to meet objectives
• Identifying and securing key project resources
• Adhering to corporate methodology and maintaining artifacts
• Defining and reporting key measures of success
• Implementing project change requests and corrective actions to ensure project success
• Consistently communicating to internal and external stakeholders outlining status, risks & issues
• Working effectively with business partners, vendors, technology, and the project team

Qualifications:

• PMP certification ideal.
• 2-4 years of PM experience.
• Experience on IT sector. Healthcare informatics ideal.
• Minimum bachelor’s degree in Engineering. or IT-related field.
• Travel 25% or less
• Need to be a self-starter and not just manage tasks
• Demonstrated knowledge of industry best practices
• Exposure to multiple project management methodologies and tools

Education:
Bachelor’s degree in a technical field, or equivalent experience.

Job Responsibilities:

Coordinate activities of TeraRecon’s Quality Management System, this can include but may not be limited to the following:

• Document Control Coordinator: Ensure documents for release follow TeraRecon’s document control and record control procedures
• Training Coordinator: Ensure required training is assigned appropriately to individuals and it is being completed
• Corrective and Preventative Action Coordinator: Track execution of corrective and preventative actions and ensure they follow TeraRecon’s procedure
• Non-Conformance Coordinator: Track execution of non-conformances and ensure they follow TeraRecon’s procedure
• Internal Audits: Track execution of internal audits per the defined Internal Audit Schedule to ensure that they follow TeraRecon’s procedure

Monitor TeraRecon’s Quality Management System process and provide insight on the business’ compliance to the QMS, this can include but may not be limited to the following:

• Develop process monitoring metrics to determine compliance to TeraRecon’s Quality Management System and identify activities which need attention to meet defined planned goals and potential areas of non-conformance to correct prior to systemic issues developing.

Execute the processes defined by TeraRecon’s Quality Management System, this can include but may not be limited to the following:

• Document Control: Review and approve documentation which you are assigned as the subject matter expert. Share knowledge and train company employees on how to follow TeraRecon’s document control process utilizing any tools that TeraRecon as in place to facilitate the process.
• Training: Determine and document training requirements for documents utilized in TeraRecon’s Quality Management System. Set-up and execute training working cross functionally as required to determine training needs and competency assessments.
• Corrective and Preventative Actions: Execute CAPA investigations, root cause assessments, corrective action plans and effectiveness verifications.
• Non-Conformances: Execute Non-Conformance investigations, determine appropriate dispositions for non-conforming product, and execute corrective action plan.
• Internal Audits: Execute in conjunction with a lead auditor internal audits per TeraRecon’s defined internal audit schedule. Develop the audit plan, propose non-conformances and opportunities for improvement to be discussed by the audit team, and document areas of conformity showing how the business is compliant to its Quality Management System.
• Design Control and Change Control: Draft, author, review, and/or approve design control and change control deliverables which are generated through execution of design projects following TeraRecon’s defined procedures.
• Computer System Validation: Author, review, and/or approve deliverables generated from execution of computer system validation projects at TeraRecon to move to production use systems which are utilized by the business in development and surveillance of a medical device pre- and post-market.
• Process Validation: Author, review, and/or approve deliverables required to validate processes which are utilized by TeraRecon in development and surveillance of a medical device pre- and post- market.

Qualifications:

• 2-4 years working as part of a Quality Team at a medical device manufacturer, with experience executing at least two of the following Quality Management System processes: Document Control, Training, Corrective and Preventive Actions, Non-Conformances, Internal Audits, Design Control and Change Control, Computer System Validation, and/ or Process Validation.
• Knowledge and experience of working in a QMS which has processes compliant to ISO 13485, ISO 14971, and IEC 62304 (prefer knowledge and experience with IEC 82304 and IEC 62366 in addition)

Education

Completion of an undergraduate degree (preferably a Bachelor of Science in an engineering discipline such as Biomedical Engineering or System Engineering), work experience can substitute for degree requirement

Responsibilities

• Plan, design, implement and test integration components under no guidance.
• Draft and execute test protocols from design/functional specifications throughout the entire development process.
• Ensure that the product meets the user and design requirements.
• Prepare and maintain test environments to replicate real world environment.
• Implement and execute component and end-to-end integration tests, working closely within the scrum team.
• Lead and implement testing of neural networks (black-box testing, white-box testing) – Data Science team.
• Document defects and troubleshoot issues. Find bugs in the software proactively prior an engineering release.
• Develop test automation for successfully executed tests as needed.
• Writes documentation for assigned integration components; organizes the review and/or release of documentation when required; ensures alignment with the designs of the systems being integrated and the overall solution architecture.
• And more.

Requirements (must)

• At least 5 years of experience in the medical imaging industry and healthcare IT
• Experience with testing, troubleshooting or using medical imaging viewers is required.
• Networking: Use of network commands/tools in troubleshooting issues related to data transfer across a network (required).
• Familiarity with DICOM configuration, connection testing and troubleshooting is required.
• Experience with PACS systems, RIS and knowledge of HL7 is required.
• Understanding of Machine Learning development principles is required (Data Science Team).
• Experience with white-box testing, python scripting and API programming is required (Data Science Team).
• Experience with testing of AI software components is required (Data Science team)
• Strong knowledge of Windows Platform, Docker and Linux environment.
• Ability to troubleshoot hardware and software quickly and efficiently.
• Able to work independently under no supervision with good time management skills.

Requirements (desired)

• 15 years of experience or more in Software Quality Assurance
• 5+ years of experience with test automation tools and frameworks is desired.
• Medical skills: Knowledge about human anatomy and medical imaging & knowledge of advanced post-processing tools and techniques for CT or MR are highly desired.
• Experience of installing databases (SQL), VMs, computer networks, firewall, network security, and systems integration is highly desired.
• Experience or knowledge in DevOps is an advantage (desired)

Education

• B.S. Degree in Computer Engineering, Electrical & Electronics Engineering, or related fields

Responsibilities

• Migrate existing MS SQL interfaces and store procedures into PostgreSQL in cloud
• Improve performance and documentation of existing back-end data services, and implement new ones
• Troubleshoot and support existing database processes; deliver fixes and optimizations where appropriate.
• Stay on top of tech trends, experimenting with and learning new technologies, and mentoring other members of the engineering team

Qualifications

• Minimum of 5 years of experiences in developing and optimizing relational databases and writing MSSQL and/or PostgreSQL
• Understanding of normalization, indexing, and other database design concepts, and where these are and aren’t applicable.
• Background in cloud technologies and platforms, such as AWS RDS and S3 is a plus
• Willingness to take on hard problems and suggest and then implement solutions

Education

• BS in Engineering, Biomedical Engineering or related field is required.

Responsibilities

• Develop iNtuition server related technologies – web development, systems integration, rendering, DICOM/HL7.
• Working on servers in the area of clustering, storage, database, network optimization, dockerization, virtualization.
• Understand requirements of requests and develop design documents.
• Trouble-shooting field issues related to the server backend and the integration with third-party RIS/PACS and/or applications.
• Stay on top of tech trends, experimenting with and learning new technologies, and mentoring other members of the engineering team

Qualifications

• 7+ years of experience with one or more areas of server development, visualization, networking, trouble shooting and problem isolation.
• 7+ years of C++ or C# or JavaScript experience in Windows application developments.
• Deep understanding of algorithms, design patterns, debugging and performance optimization.
• Experience in medical imaging and diagnostic review software, PACS systems and knowledge of DICOM and other related medical imaging standards and protocols is highly desired.
• Knowledge of databases and SQL programming, server and clustering technology desired.
• Some familiarity and experience using AWS and/or other cloud computing platforms (IaaS, PaaS, SaaS) is a plus
• Familiarity with working in a regulated environment (ISO, FDA, CMDCAS and CE Marking Directive, etc.) is helpful.

Education

• BS in Engineering, Biomedical Engineering or related field is required.

Required Qualifications:

• At least 3 years of experience in C# .NET, ASP.NET Core MVC, or windows applications development using WinForms/WPF.
• Experience with one or more front end development frameworks like Angular or React.
• Experience working with cloud-based applications and knowledge of cloud infrastructure such as Amazon web services or Microsoft Azure.
• Experience with Restful APIs using .NET Core.
• Experience with relational SQL and NoSQL databases.
• Solid understanding of object-oriented design and programming concepts.
• Experience with web development and debugging tools.
• Experience working within Agile / Scrum based development processes.
• Experience developing and deploying medical applications in a medical enterprise environment is a plus.

Desired Qualifications:

• Experience developing 2D/3D image processing algorithms such as 3D image transformations and 2D image segmentation.
• Knowledge of DICOM, HL7, and other related medical imaging standards and protocols.
• 3D programming experience (geometry, volumetric and surface rendering using WebGL).
• 2D Imaging experience.
• Back-end web development experience.
• Experience working within Agile / Scrum based development processes.
• Experience with version control systems such as Git or SVN.

Education:

• Bachelor’s degree or higher in computer science, computer engineering or related field.

Responsibilities

• Designing, developing, and implementing algorithms, visualization tools and advanced analysis modules for medical data including CT and MR
• Develop 3D medical image processing algorithms using DICOM and Merge Toolkit
• Implement applications in C++, Phython, Java
• Write engineering documentation and provide technical support during entire lifecycle
• Documentations of the design, implementations and test planning for the modules, and providing code review for other members

Qualifications

• Minimum of 3 years of professional experience developing C++ software.
• Experience with rendering software, for example CUDA, OpenGL, or VTK.
• Strong math, especially geometry skills.
• Solid understanding of object-oriented design and programming concepts.
• Experience using Git version control is a plus.
• Experience working within Agile / Scrum based development processes.
• Experience in medical imaging and diagnostic review software, PACS systems and knowledge of DICOM and other related medical imaging standards and protocols is a plus.
• Familiarity with working in a regulated environment (ISO, FDA, CMDCAS and CE Marking Directive, etc.) is helpful.

Education

• B.S. Degree in Computer Science or related fields