Jobs at Capstan Medical

Support structural heart valve product quality from development through production readiness and release. Lead design controls, risk management, verification/validation, sterilization and microbiology testing, acceptance activities, cleanroom operations, CAPA/NCR/MRB, and continuous improvement. Collaborate cross-functionally with R&D, Operations, Regulatory, suppliers, and labs to ensure compliance with device quality systems and applicable standards.

Lead design and implementation of end-of-line, hardware-in-the-loop, and CI/CD test frameworks for capital, implant, and delivery systems. Integrate and debug hardware/software, run stress/load tests, aggregate manufacturing and field data for analysis, and provide actionable feedback to engineering teams to improve design, manufacturing consistency, and clinical performance.

Support and manage medical device clinical studies for mitral and tricuspid valve products. Oversee site start-up, monitoring, data entry/query resolution, regulatory/IRB submissions, CRO management, safety event reporting, TMF and CTMS maintenance, site payments, and coordination of CEC/DSMB activities. Collaborate cross-functionally to ensure compliance and study progress.

Lead clinical development activities for a transcatheter medical robotics platform: design and pre-clinical testing, support clinical trials and data collection, analyze clinical data, collaborate with physicians and cross-functional teams, and assist technical documentation and regulatory-aligned processes.

Lead electromechanical integration and troubleshooting of robotic systems; triage and resolve cross-functional hardware/software issues; build and commission prototypes; run tests and simulations; support manufacturing and field teams; define system/subsystem requirements and document manufacturability and reliability learnings.

Lead mechanical design for a medical robotic platform from concept to product. Build and bring up prototypes, collaborate cross-functionally, document design and verification, mentor teammates, and drive manufacturability and reliability for pre-clinical and product development.

Support product quality for structural heart implant, delivery, and robotic devices. Lead sterilization and packaging validations, finished goods release, cleanroom production oversight, NCR/CAPA investigations, MRB participation, audits, documentation, and regulatory compliance (FDA QSR, ISO 13485). Collaborate with R&D, Regulatory, Manufacturing, and Engineering to resolve quality issues and drive process improvements.

Lead end-to-end execution of the robotic transcatheter valve program: manage detailed MS Project schedules, drive design control compliance and DHF, facilitate meetings, oversee V&V, clinical trials and regulatory submission, manage vendors, mentor junior project leads, and provide cross-functional status and mitigation to leadership onsite.

Design, implement, and verify robotic control algorithms for a catheter-based surgical platform. Develop kinematic/dynamic models, motion planning, state estimation, and safety-aware control. Characterize hardware, run verification and validation, support regulatory submissions, mentor engineers, and drive architecture across hardware programs from prototype to product.

Lead day-to-day implant manufacturing operations and supervise technicians to meet production schedules, quality, and safety goals. Drive workforce planning, training, metrics (throughput, yield, labor utilization), investigations (NCRs, deviations), root cause analysis, corrective actions, and Lean Six Sigma process improvements supporting R&D, validation, and clinical builds.

Lead scaling and sustaining production for Capstan accessories and single-use devices. Develop and improve manufacturing processes, create documentation, troubleshoot floor-level issues, own component engineering and supplier nonconformances, lead root cause and corrective actions, and collaborate with Quality, Supply Chain, R&D, and suppliers to resolve quality, yield, and performance issues.

Support clinical screening by measuring and analyzing CT and echocardiography, building imaging-processing infrastructure, modeling anatomies, collaborating on preclinical screening, developing protocols and education materials, and working with cross-functional teams and clinical partners.

Design and implement software for a multi-process real-time robotic medical system. Develop services coordinating system state, ensure safe operation, profile and optimize performance, implement security hardening, collaborate with hardware and controls teams, and support verification/validation for regulatory compliance.

Manage electronic document control workflows (Propel), track change orders, draft and maintain SOPs/WIs/forms, organize SharePoint quality records, maintain standards library, support training and audits, and assist QA activities including DHR and NCR documentation support.

Support manufacturing quality for a robotic medical device platform: lead nonconformance investigations and CAPAs, run process validations (IQ/OQ/PQ), maintain DHRs, perform audits, support packaging/finished goods release, and apply risk management (Process FMEA) and continuous improvement (Lean/Six Sigma).

Provide design quality support for the robotic surgical platform by executing design control activities, risk management (DFMEA/UFMEA), reviewing/approving verification and validation protocols/reports, maintaining design history and risk files, supporting audits, driving CAPAs, and identifying quality system improvements to ensure regulatory and standards compliance (ISO 13485, 21 CFR 820.30).

Coordinate and support full-cycle recruiting and People Operations tasks: manage job postings, schedule interviews, maintain ATS records, assist hiring managers, support offers and onboarding, handle background checks and HR documentation, generate recruiting reports, and support employee lifecycle and people programs to ensure a positive candidate and employee experience.