Senior Software Engineer – Medical Imaging

This is a fully remote position, open to applicants in New York, +1 more state.

📋 Description

• Design, develop, configure, enhance, and maintain applications tailored for specific projects that support clinical trial endpoints, imaging review, operational workflows, and sponsor deliverables.

• Convert clinical, scientific, protocol, operational, and data requirements into technical specifications, application logic, workflows, reports, and user-facing features.

• Build and maintain systems for blinded independent central review, eligibility review, endpoint review, reader assignment, discrepancy management, adjudication, consensus workflows, and audit trails.

• Facilitate image transfer, de-identification, reconciliation, quality control, storage, viewing, measurement, review, archival, and data delivery workflows.

• Create solutions that ensure a consistent end-to-end data flow across protocols, eCRFs, clinical databases, imaging platforms, assessment applications, operational reports, and sponsor deliverables.

• Lead and support the processes of requirements gathering, solution design, development, testing, validation, UAT, deployment, release management, production support, and continuous improvement.

• Ensure traceability across protocol requirements, Independent Review Charters, business requirements, specifications, technical design, tests, validation evidence, and training materials.

• Assist in risk assessments, impact assessments, root cause analysis, CAPA activities, audit readiness, validation documentation, and regulated change control.

• Drive process improvement initiatives aimed at enhancing quality, standardization, scalability, efficiency, predictable delivery, and reducing rework.

• Develop reusable development standards, build standards, application templates, testing frameworks, training content, and operational playbooks.

• Provide technical input for RFIs, sponsor assessments, client audits, demonstrations, solution design discussions, and feasibility reviews.

• Act as a senior technical advisor for cross-functional teams and leadership.

• Mentor engineers and analysts while fostering knowledge sharing.

• Serve as a senior technical contributor and domain expert for project-specific clinical trial application builds.

• Identify delivery risks, technical gaps, process inefficiencies, and opportunities for modernization.

• Support reliable, traceable, end-to-end data management from study setup through review, adjudication, reporting, and delivery.

• Travel approximately 15% as required for business, sponsor, audit, training, or project needs.

⛳️ Requirements

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, Clinical Informatics, Information Systems, Life Sciences, or a related field.

• Extensive experience in software engineering, clinical trial technology, medical imaging technology, healthcare technology, or regulated software development environments.

• Background in supporting clinical research, CROs, pharmaceutical or biotechnology organizations, medical imaging providers, imaging core labs, centralized review organizations, or clinical technology vendors.

• Direct experience with centralized imaging review organizations and blinded independent review workflows, including BICR, endpoint adjudication, reader workflows, discrepancy resolution, and imaging review operations.

• Experience in translating clinical trial protocols, imaging manuals, Independent Review Charters, data collection requirements, and sponsor requirements into application functionality and technical solutions.

• Familiarity with medical imaging, centralized review, endpoint assessment, clinical data capture, data reconciliation, and operational reporting systems.

• Strong experience with regulated SDLC, validation, quality, and change control frameworks.

• Ability to independently evaluate competing priorities and make decisions based on study-specific risk and operational needs.

• Proficiency in Python, Java, SQL, REST APIs, JavaScript, or related web technologies, database design, application architecture, workflow automation, source control, CI/CD, and release management.

• Required experience in BPM or workflow orchestration.

• Knowledge of EDC, eCRF design, clinical databases, clinical data review systems, CTMS, study management tools, operational reporting, data exports, and clinical data integrations.

• Familiarity with DICOM standards, image transfer workflows, imaging archives, imaging viewers, image QC, reader platforms, annotation and measurement tools, central review platforms, and AI-enabled imaging solutions.

• Understanding of Computer System Validation, risk-based validation, UAT, traceability matrices, test scripts, validation evidence, audit trails, GxP, GAMP 5, 21 CFR Part 11, ICH-GCP, EU Annex 11, HIPAA, and GDPR.

• Working knowledge of imaging and endpoint assessment criteria across therapeutic areas.

• Willingness to travel approximately 15%.

• Legal authorization to work in the country where the role is based.

• Advanced degree is preferred.

• Strong preference for candidates with Camunda BPM experience.

• Preferred experience with AI-assisted imaging analysis, quantitative imaging, segmentation, volumetric analysis, radiomics, or machine-learning-enabled imaging workflows in regulated clinical research settings.

• At least 8 years of experience supporting imaging CROs, medical imaging core labs, independent review organizations, eClinical technology providers, or clinical trial technology vendors is preferred.

• Experience in sponsor-facing solution design, technical feasibility assessment, RFI/RFP support, client audits, and regulatory inspection support is preferred.

• Background in leading modernization initiatives, workflow automation, technical debt remediation, and process improvement is preferred.

• Experience in mentoring technical team members and establishing organizational knowledge management practices is preferred.

🏝️ Benefits

• Competitive base salary with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• Reasonable accommodations available during the recruitment process.

• Flexible office or home work arrangements.