Jobs at Carlsmed

Manages quality systems for medical device products, including CAPA, audits, change control, documentation, field actions, regulatory compliance, and quality metrics. Leads root cause analysis, corrective action planning, audit scheduling and execution, regulatory audit support, standards gap assessments, process improvement projects, and quarterly quality trend reporting. Requires medical device quality assurance experience, lead auditing, regulatory standards knowledge, advanced Excel and PowerPoint skills, and strong technical communication.

Provide organization-wide technical leadership for Carlsmed’s personalized spine surgery software platform. Define platform architecture, technical vision, standards, governance, and technology strategy. Guide Node.js microservices, GraphQL federation, React applications, PostgreSQL solutions, APIs, distributed systems, and proof-of-concept initiatives. Mitigate technical risks, lead major architectural decisions, collaborate with senior leadership, and mentor senior engineers and technical leads.

Oversee and improve IT systems, infrastructure, and services while supporting reliable, secure, and efficient operations. Implement IT strategy, enforce policies and compliance with HIPAA and FDA requirements, conduct audits and security assessments, coordinate IT projects, resolve business application disruptions, and maintain service desk and operational documentation.

Drive regional revenue and market expansion for the aprevo spine platform. Build and manage sales agent network, engage surgeons and hospital stakeholders, onboard customers, document activities in CRM, provide technical surgical support, meet training and budget targets, and travel frequently within Southern California.

Work with patient CT data to create complex 3D surface and solid CAD models for personalized spinal implants and instrumentation. Collaborate with engineers, clinicians, and suppliers, produce design control documentation, review models with customers, and support production, testing, and R&D tasks.

The Senior Software Engineer will design scalable backend services, develop frontend applications, optimize databases, and mentor junior engineers while collaborating with product managers.

Lead finance and accounting for supply chain and production operations, owning cost accounting, standard costing, inventory tracking, variance analysis, ERP (NetSuite) implementation co-lead, operational KPIs, forecasting, month/quarter/year close for inventory and COGS, and support audits and process improvements.

Design and validate intuitive, clinically meaningful interfaces for a surgical planning platform through user research, prototyping, usability testing, and design-system contributions, collaborating with product, engineering, clinical, and regulatory teams.

Manage surgeon onboarding, training, and adoption of aprevo surgical platform across a Northeast territory. Build relationships with clinic staff, ensure required imaging and patient information, grow aprevo user base, support marketing and sales initiatives, maintain CRM and reporting, and present clinical data to drive utilization and revenue.