AI Software Engineering Clinical Systems

CSBio•Milpitas, CA

About The Position

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. CSBio brings more than three decades of peptide and cGMP manufacturing experience, while Yowei Therapeutics is developing clinical programs in peptide therapeutics. The role involves designing, building, testing, deploying, and maintaining internal applications, dashboards, data tools, and workflow systems. The engineer will develop AI-assisted features using approved models and services, create evaluations and safeguards for AI quality and security, build responsive interfaces and backend services, design secure data systems, and integrate approved internal and external platforms. The position also includes production support, documentation, vendor evaluation, protection of confidential and regulated information, and technical guidance for interns or junior developers. For clinical and regulated systems, the engineer may build or configure study databases, eCRFs, visit workflows, operational trackers, and dashboards. The role supports approved requirements, testing, controlled releases, integrations, data transfers, and technical records, while clinical, medical, safety, statistical, regulatory, privacy, and Quality decisions remain with qualified owners.

Requirements

Bachelor’s degree in computer science, software engineering, data science, information systems, engineering, or a related field, or equivalent demonstrated professional experience.
At least 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 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 convert loosely defined operational needs into clear requirements and working software while communicating tradeoffs and risks to non-technical teams.

Nice To Haves

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.

Responsibilities

Design, build, test, deploy, and maintain internal web applications, dashboards, data tools, and workflow systems supporting company operations.
Develop and improve systems for employee, project, operational, clinical, laboratory, or manufacturing workflows.
Build AI-assisted features such as document processing, structured extraction, search, retrieval-augmented generation, summarization, classification, and agent-assisted workflows using approved models and services.
Create evaluation datasets, test cases, guardrails, logging, and human-review workflows to assess AI quality, reliability, security, and failure modes.
Build responsive user interfaces and reliable backend services using appropriate web, database, and API technologies.
Design database schemas, permissions, role-based access, authentication, audit logging, backups, and secure data flows.
Integrate approved internal and external systems, including laboratory, specimen, device, pharmacy, participant, project-management, and collaboration platforms.
Translate operational problems and user feedback into requirements, technical designs, staged releases, and maintainable software.
Write automated tests, perform code reviews, manage source control, document defects, and establish development, release, rollback, and incident-response procedures.
Monitor deployed applications, investigate performance and reliability issues, correct defects, and communicate risks and outages 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, and escalate architecture, security, privacy, and regulated-system decisions when needed.
Evaluate software vendors, AI tools, and technical proposals, documenting security, data-use, integration, portability, and vendor-exit considerations.
Protect confidential, participant, clinical, genomic, CMC, manufacturing, and QC information and follow approved data-classification, access, and retention requirements.
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 for access control, version history, change management, validation evidence, backups, recovery, and vendor exit as required.

Benefits

Medical, dental, and vision insurance, with Kaiser HMO or BlueShield PPO medical options; the employer pays 85% for the employee and 50% for the employee’s family.
Dental coverage options include Aetna Dental, Delta Dental, Guardian Dental, and MetLife Dental.
Vision coverage options include VSP and Aetna EyeMed.
Basic life insurance of $20,000 paid by the company, with optional supplemental life insurance.
Disability insurance with 50% standard employer-paid coverage.
401(k) with a 10% 1:1 match.
10 days of PTO.
Companywide paid holidays during the week of July 4, two days at Thanksgiving, and the 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.