AI Software Engineering Clinical Systems

CSBio and Yowei Therapeutics are seeking a hands-on AI Software Engineer to build internal applications, AI-assisted workflows, data systems, and secure automations supporting clinical, laboratory, manufacturing, and company operations. Job Duties: - Design, build, test, deploy, and maintain internal web applications, dashboards, data tools, and workflow systems supporting CSBio and Yowei Therapeutics. - Develop and improve internal systems used for employee, project, operational, clinical, laboratory, or manufacturing workflows. - Build AI-assisted features using approved models and services, including document processing, structured extraction, search, retrieval-augmented generation, summarization, classification, and agent-assisted workflows. - Create evaluation datasets, test cases, guardrails, logging, and human-review workflows to measure AI quality, reliability, security, and failure modes before release. - Build responsive user interfaces and reliable backend services using technologies such as TypeScript or JavaScript, React or Next.js, Python, SQL, PostgreSQL or Supabase, and REST or event-driven APIs. - Design database schemas, permissions, role-based access, authentication, audit logging, backups, and secure data flows appropriate to each application. - Integrate approved internal and external systems, including laboratory, specimen, device, pharmacy, participant, project-management, and collaboration platforms. - Translate operational problems and user feedback into clear requirements, technical designs, staged releases, and maintainable software rather than one-off prototypes. - Write automated tests, perform code reviews, manage source control, document defects, and establish practical development, release, rollback, and incident-response procedures. - Monitor deployed applications, investigate performance or reliability issues, correct defects, and communicate risks and outages clearly to users and leadership. - Create technical documentation, architecture diagrams, data dictionaries, user guides, setup instructions, and training materials. - Provide technical guidance, code review, and structured assignments to interns or junior developers while escalating architecture, security, privacy, and regulated-system decisions when needed. - Evaluate software vendors, AI tools, and technical proposals; document security, data-use, integration, portability, and vendor-exit considerations before adoption. - Protect company-confidential, participant, clinical, genomic, CMC, manufacturing, and QC information and follow approved data-classification, access, and retention requirements. Clinical and Regulated Systems Responsibilities: - Build or configure fit-for-purpose study databases, eCRFs, visit workflows, operational trackers, and clinical dashboards when assigned. - Implement approved fields, validation rules, edit checks, controlled terminology, role-based access, audit trails, exports, and user workflows based on requirements supplied or approved by qualified clinical and data owners. - Support testing, user-acceptance testing, defect correction, controlled releases, integrations, data transfers, and sponsor-controlled exports. - Support clinical and laboratory system integrations without independently making protocol, medical, safety, statistical, regulatory, privacy, or Quality decisions. - Maintain technical records supporting access control, version history, change management, validation evidence, backups, recovery, and vendor exit as required for the system. Requirements - Bachelor's degree in computer science, software engineering, data science, information systems, engineering, or a related field, or equivalent demonstrated professional experience. - 3+ years of experience building, deploying, and maintaining production software applications, internal platforms, data products, or comparable business-critical systems. - Strong working proficiency with TypeScript or JavaScript, Python, SQL, and modern web-development practices. - Experience with React, Next.js, or a comparable frontend framework and with PostgreSQL, Supabase, or another relational database platform. - Experience designing and integrating APIs, authentication, authorization, role-based permissions, data models, and secure application workflows. - Hands-on experience integrating LLM APIs or approved AI models into working applications, with practical attention to testing, evaluation, failure handling, privacy, and human review. - Experience with Git or GitHub, code review, automated testing, debugging, documentation, deployment, and production support. - Ability to independently convert loosely defined operational needs into clear requirements and working software while communicating tradeoffs and risks to non-technical teams. Preferred Qualifications: - Experience with retrieval-augmented generation, embeddings, vector search, structured outputs, document extraction, agent workflows, model evaluation, or AI observability. - Experience with Vercel, cloud infrastructure, CI/CD, background jobs, queues, monitoring, logging, secrets management, or infrastructure-as-code. - Experience building internal tools for biotechnology, pharmaceutical manufacturing, laboratories, clinical research, healthcare, or another regulated environment. - Familiarity with EDC, eCRFs, CTMS, eSource, LIMS, REDCap, laboratory-data systems, or clinical-data integrations. - Knowledge of GCP, 21 CFR Part 11, audit trails, computer-system validation, data integrity, privacy, or regulated change-control practices. - Experience mentoring interns or junior developers and establishing practical engineering standards for a small team. Benefits - Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed) - Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental). - Disability insurance 50% standard employer paid. - 401k 10% 1:1 match - PTO policy. 10 days PTO - Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25 - Carpool, clean air vehicle, and cell phone reimbursement - Employee rewards and recognition program - Company organized social events - Quarterly sponsored team building activities